Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial (MS-LIFG-HDtDCS)
The purpose of the study is to test whether low-level electric stimulation, called High Definition transcranial Direct Current Stimulation (HDtDCS), on the part of the brain (i.e., left inferior frontal gyrus) thought to aid in memory will improve verbal retrieval in multiple sclerosis patients. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures.
Descripción general del estudio
Estado
Descripción detallada
Using two treatment arms, the study will examine improvement of verbal retrieval and other cognitive deficits associated with multiple sclerosis by comparing (1) 1 milliamp of High Definition transcranial Direct Current Stimulation (HDtDCS) active treatment applied to left inferior frontal gyrus for 20 minutes over 10 sessions to (2) sham HDtDCS following the same schedule. Additionally, after completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, participants will complete a second set of 10 sessions where they will switch conditions (i.e., those who received active stimulation will be switched to sham, and vice versa), and the will be re-evaluated at immediate and 2-month follow-up testing sessions.
Patients with multiple sclerosis and observed cognitive deficits will be randomly assigned to one of the two treatment arms (and re-assigned for the second round of intervention, as described above). Primary outcome verbal retrieval measures, secondary neuropsychological and electroencephalography (EEG) measures, and prescreening assessments for study concussion history and contraindications for treatment will be collected prior to being assigned to a treatment arm (i.e., baseline).
Primary outcome verbal retrieval measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected at baseline and two times following each treatment competition (i.e., immediate and 2-months).
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Richardson, Texas, Estados Unidos, 75080
- Callier Clinical Researcher Center
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Investigador principal:
- John Hart, Jr, MD
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Contacto:
- Tyler Vintila, MS
- Número de teléfono: 972-833-3161
- Correo electrónico: Tyler.Vintila@UTDallas.edu
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Contacto:
- Jill Ritter, BA
- Número de teléfono: 972-833-3161
- Correo electrónico: jill.ritter@utdallas.edu
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Sub-Investigador:
- Michael A Motes, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participants must be between the ages of 18 and 64;
- Participants must have a diagnosis of relapsing-remitting multiple sclerosis (RRMS). A physician's note verifying RRMS will be required if they are a patient outside the UT Southwestern network;
- Participants must have a validated memory deficit: Validation will be done via neuropsychological testing at the initial/baseline visit using the Semantic Object Retrieval Test (SORT), COWAT (letter and category fluency), Boston Naming Test (BNT), and Auditory Verbal Learning Test (AVLT); neuropsychological test score on at least one verbal retrieval assessment (COWAT, BNT, AVLT) of a T-score less than 40 or a verbal retrieval test that was greater than 1.0 SD below the average T-score on SORT;
- Participants must be fluent in speaking and reading English because testing materials are not available in other languages.
Exclusion Criteria:
- Relapse or acute MS exacerbation during the two months (60 days) preceding the baseline testing, with re-evaluation for inclusion possible after the 60 days of stability;
- Less than 3 months (90 days) on a stable dose of benzodiazepines or modaphinil/armodafinil;
- A history of a neurological disorder, other than RRMS, including dementia of any type, epilepsy or other seizure disorders, brain tumor, present drug abuse, stroke, blood vessel abnormalities in the brain, Parkinson's disease, or - - Huntington's disease;
- Epilepsy or other seizure disorder;
- Severe traumatic brain injury;
- Unexplained episodes of loss of consciousness;
- Suffering frequent headaches;
- Unstable or uncontrolled psychiatric illness;
- Brain tumor;
- Serious or life-threatening diseases, including congestive heart failure, chronic obstructive pulmonary disease, or active malignancy;
- Stroke;
- Head implant or skull defects/damage that would affect HDtDCS administration or EEG recording;
- Use of brain medical device;
- Cardiac, neural, or medication implants that would affect HDtDCS administration or EEG recording;
- Vascular clip;
- Scalp skin condition like dermatitis, psoriasis, or eczema;
- Current substance abuse, less than 1 year of discontinuation; Pregnancy;
- Cognitive impairment due to an issue other than RRMS;
- Telephone-administered Montreal Cognitive Assessment (TMoCA) Score <19, unless accompanied by a legally authorized representative (LAR) to the consenting session;
- Montreal Cognitive Assessment (MoCA) Score <23, unless accompanied by an LAR to all sessions and both the participant and LAR provide consent; Not being able to give informed consent, unless accompanied by an LAR to all sessions and both the participant and LAR provide consent, and with consent ability assessed with a set of comprehension questions regarding the study and consenting to participate and with MoCA criteria above;
- Medication Restrictions: Certain medications can temporarily change how your brain responds to electrical stimulation or affect EEG signals, and therefore are exclusionary: 1) Known medications that interact with tDCS efficacy: anti-convulsants, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole; 2) Medications that lower the seizure threshold; 3) Stimulant Medications (e.g., Adderall, Ritalin, often used for MS-related fatigue) cannot be taken during the course of the study; enrollment can be considered if the participant is willing to suspend use over the course of the study and suspension is coordinated with the prescribing physician); suspension must occur at least 3 days before any assessment session and must be maintained over the HDtDCS treatment phases of the study;
- Steroid Medications (e.g., Prednisone, Decadron, IV Solu-Medrol, often used for MS relapses or inflammation treatment); If a participant has taken prescription steroid pills or received a steroid IV, they must wait at least 2 months (60 days) after your last dose before you can start tDCS treatments, although baseline testing will permissible within this 2-month waiting period.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: High Definition transcranial Direct Current Stimulation
High Definition transcranial Direct Current Stimulation (HDtDCS) will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode F7 (International 10/10 System for electroencephalography electrode placement) and electrodes T7, FP, AF3, and FC5 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via saline connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds. |
High Definition transcranial Direct Current Stimulation (HDtDCS) will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode F7 (International 10/10 System for electroencephalography electrode placement) and electrodes T7, FP, AF3, and FC5 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via saline connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.
Otros nombres:
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Comparador falso: Sham High Definition transcranial Direct Current Stimulation
Sham High Definition transcranial Direct Current Stimulation (HDtDCS) will be delivered via a Neuroelectrics Starstim tES. The setup will consist of placing electrodes at F7, T7, FP, AF3, and FC5 (International 10/10 System for electroencephalography electrode placement). All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via saline connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp back down to 0 milliamps over 60 seconds, and then remain at 0 milliamps over 20 minutes. |
Sham High Definition transcranial Direct Current Stimulation (HDtDCS) will be delivered via a Neuroelectrics Starstim tES. The setup will consist of placing electrodes at F7, T7, FP, AF3, and FC5 (International 10/10 System for electroencephalography electrode placement). All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via saline connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp back down to 0 milliamps over 60 seconds, and then remain at 0 milliamps over 20 minutes.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Category Fluency
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Category Fluency following treatment Period 1. Category Fluency is a timed assessment with standardized scoring rules, where higher scores indicate fluency improvement. Metric: Number of Correct Items Generated |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Category Fluency
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Category Fluency following treatment Period 2. Category Fluency is a timed assessment with standardized scoring rules, where higher scores indicate fluency improvement. Metric: Number of Correct Items Generated |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Verbal Fluency
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Verbal Fluency following treatment Period 1. Verbal Fluency is a timed assessment with standardized scoring rules, where higher scores indicate fluency improvement. Metric: Number of Correct Items Generated |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Verbal Fluency
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Verbal Fluency following treatment Period 2. Verbal Fluency is a timed assessment with standardized scoring rules, where higher scores indicate fluency improvement. Metric: Number of Correct Items Generated |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Auditory Verbal Learning Test Delayed Memory
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Auditory Verbal Learning Test delayed memory following treatment Period 1. The Auditory Verbal Learning Test is a standardized list-learning test, where higher scores indicate memory improvement. Metric: Number of Correct Items Recalled |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Auditory Verbal Learning Test Delayed Memory
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Auditory Verbal Learning Test delayed memory following treatment Period 2. The Auditory Verbal Learning Test is a standardized list-learning test, where higher scores indicate memory improvement. Metric: Number of Correct Items Recalled |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period 1 Picture Description Test Words Per Minute
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in the Picture Description Test words per minute following treatment Period 1. Picture Description Test is a standardized assessment with scoring rules, where higher scores indicate word per minute improvement. Metric: Number of Words per Minute |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Period Picture Description Test Words Per Minute
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in the Picture Description Test words per minute following treatment Period 2. Picture Description Test is a standardized assessment with scoring rules, where higher scores indicate word per minute improvement. Metric: Number of Words per Minute |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 Period Picture Description Test Main Concepts Score
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in the Picture Description Test main concepts following treatment Period 1. Picture Description Test is a standardized assessment with scoring rules, where higher scores indicate greater main concept identification improvement. Metric: Number of Main Concepts |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Picture Description Test Main Concept Scores
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in the Picture Description Test main concepts following treatment Period 2. Picture Description Test is a standardized assessment with scoring rules, where higher scores indicate greater main concept identification improvement. Metric: Number of Main Concepts |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 Period Picture Description Test Core Lexicon Score
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in the Picture Description Test Core Lexicon Score following treatment Period 1. Picture Description Test is a standardized assessment with scoring rules, where higher scores indicate greater Core Lexicon use. Metric: Core Lexicon Production |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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12. Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Picture Description Test Core Lexicon Score
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in the Picture Description Test Core Lexicon Score following treatment Period 2. Picture Description Test is a standardized assessment with scoring rules, where higher scores indicate greater Core Lexicon use. Metric: Core Lexicon Production |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 Boston Naming Test Score
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in confrontational naming scores on the Boston Naming Test following treatment Period 1. The Boston Naming Test is a standardized assessment with scoring rules, where higher scores indicate confrontational naming improvement. Metric: Number of Items Named Correctly |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Boston Naming Test Score
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in confrontational naming scores on the Boston Naming Test following treatment Period 2. The Boston Naming Test is a standardized assessment with scoring rules, where higher scores indicate confrontational naming improvement. Metric: Number of Items Named Correctly |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Semantic Object Retrieval Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Semantic Object Retrieval following treatment Period 1. The Semantic Object Retrieval Test is a standardized assessment with scoring rules, where higher scores indicate memory retrieval improvement. Metric: Number of Correct Names Retrieved |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Semantic Object Retrieval Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Semantic Object Retrieval following treatment Period 1. The Semantic Object Retrieval Test is a standardized assessment with scoring rules, where higher scores indicate memory retrieval improvement. Metric: Number of Correct Names Retrieved |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Delis-Kaplan Executive Function System Color Word Interference Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in inhibition on the Dellis-Kaplan Executive Function System Color Word Interference Test following treatment Period 1. The Color word Interference Test is a timed assessment with standardized scoring rules, where higher scores indicate inhibitory control improvement. Metric: Number of Items Correctly Named |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Delis-Kaplan Executive Function System Color Word Interference Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in inhibition on the Dellis-Kaplan Executive Function System Color Word Interference Test following treatment Period 2. The Color word Interference Test is a timed assessment with standardized scoring rules, where higher scores indicate inhibitory control improvement. Metric: Number of Items Correctly Named |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 Delis-Kaplan Executive Function System Color Word Interference-Switching Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in inhibition on the Dellis-Kaplan Executive Function System Color Word Interference-Switching Test following treatment Period 1. The Color word Interference-Switching Test is a timed assessment with standardized scoring rules, where higher scores indicate cognitive (switching) control improvement. Metric: Number of Items Correctly Named |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Delis-Kaplan Executive Function System Color Word Interference-Switching Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in inhibition on the Dellis-Kaplan Executive Function System Color Word Interference-Switching Test following treatment Period 2. The Color word Interference-Switching Test is a timed assessment with standardized scoring rules, where higher scores indicate cognitive (switching) control improvement. Metric: Number of Items Correctly Named |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 Trail Making Test: Part A
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Trail Making Test Part A reaction time following treatment Period 1. Trail Making Test Part A is a timed assessment with standardized scoring rules, where higher scores indicate speed improvement. Metric: Time to Solution |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on Trail Making Test: Part A
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Trail Making Test Part A reaction time following treatment Period 2. Trail Making Test Part A is a timed assessment with standardized scoring rules, where higher scores indicate speed improvement. Metric: Time to Solution |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 on Trail Making Test: Part B
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Trail Making Test Part B reaction time following treatment Period 1. Trail Making Test Part B is a timed assessment with standardized scoring rules, where higher scores indicate switching speed improvement. Metric: Time to Solution |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Trail Making Test: Part B
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Trail Making Test Part B reaction time following treatment Period 2. Trail Making Test Part B is a timed assessment with standardized scoring rules, where higher scores indicate switching speed improvement. Metric: Time to Solution |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Digit Span Forward
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Digit Span Forward following treatment Period 1. Digit Span Forward is standardized assessment of working memory span, where higher scores indicate working memory improvement. Metric: Memory Span |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Digit Span Forward
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Digit Span Forward following treatment Period 2. Digit Span Forward is standardized assessment of working memory span, where higher scores indicate working memory improvement. Metric: Memory Span |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Digit Span Backward
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Digit Span Backward following treatment Period 1. Digit Span Backward is standardized assessment of working memory manipulation span, where higher scores indicate working memory improvement. Metric: Memory Span |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Digit Span Backward
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Digit Span Backward following treatment Period 2. Digit Span Backward is standardized assessment of working memory manipulation span, where higher scores indicate working memory improvement. Metric: Memory Span |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Wisconsin Card Sort Categories Achieved
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Wisconsin Card Sort categories achieved following treatment Period 1. Wisconsin Card Sort is a standardized assessment with scoring rules, where higher scores indicate executive function improvement. Metric: Number of Sort Categories Achieved |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Wisconsin Card Sort Categories Achieved
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Wisconsin Card Sort categories achieved following treatment Period 2. Wisconsin Card Sort is a standardized assessment with scoring rules, where higher scores indicate executive function improvement. Metric: Number of Sort Categories Achieved |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Judgment of Line Orientation
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Judgment of Line Orientation accuracy following treatment Period 1. Judgment of Line Orientation is a standardized assessment of visuo-spatial ability, where higher scores indicate visuo-spatial ability improvement. Metric: Number of Problems Solved Correctly |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Judgment of Line Orientation
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Judgment of Line Orientation accuracy following treatment Period 2. Judgment of Line Orientation is a standardized assessment of visuo-spatial ability, where higher scores indicate visuo-spatial ability improvement. Metric: Number of Problems Solved Correctly |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Grooved Pegboard Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Grooved Pegboard performance following treatment Period 1. The Grooved Pegboard test is a timed, standardized assessment of visuo-motor ability, where higher scores indicate visuo-motor ability improvement. Metric: Completion Time |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Grooved Pegboard Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Grooved Pegboard performance following treatment Period 2. The Grooved Pegboard test is a timed, standardized assessment of visuo-motor ability, where higher scores indicate visuo-motor ability improvement. Metric: Completion Time |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Paced Auditory Serial Addition Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Paced Auditory Serial Addition accuracy following treatment Period 1. The Paced Auditory Serial Addition Test is a timed assessment with standardized scoring rules, where higher scores indicate speed of processing improvement. Metric: Number of Correct Responses |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the on the Paced Auditory Serial Addition Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Paced Auditory Serial Addition accuracy following treatment Period 2. The Paced Auditory Serial Addition Test is a timed assessment with standardized scoring rules, where higher scores indicate speed of processing improvement. Metric: Number of Correct Responses |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Brief Visual Memory Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Brief Visual Memory Test delayed recall following treatment Period 1. The Brief Visual Memory Test is a standardized assessment with scoring rules, where higher scores indicate visual memory improvement. Metric: Number of Items Correctly Recalled |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Brief Visual Memory Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Brief Visual Memory Test delayed recall following treatment Period 2. The Brief Visual Memory Test is a standardized assessment with scoring rules, where higher scores indicate visual memory improvement. Metric: Number of Items Correctly Recalled |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Digit Symbol Substitution Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Digit Symbol Substitution accuracy following treatment Period 1. The Digit Symbol Substitution Test is a timed assessment with standardized scoring rules, where higher scores indicate processing speed improvement. Metric: Number of Correct Items |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Digit Symbol Substitution Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Digit Symbol Substitution accuracy following treatment Period 2. The Digit Symbol Substitution Test is a timed assessment with standardized scoring rules, where higher scores indicate processing speed improvement. Metric: Number of Correct Items |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Rey-Osterrieth Complex Figure Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in Rey-Osterrieth Complex Figure memory following treatment Period 1. Rey-Osterrieth Complex Figure Test is a standardized assessment with scoring rules, where higher scores indicate visuo-spatial memory improvement. Metric: Recall Score |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Rey-Osterrieth Complex Figures Test
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in Rey-Osterrieth Complex Figure memory following treatment Period 2. Rey-Osterrieth Complex Figure Test is a standardized assessment with scoring rules, where higher scores indicate visuo-spatial memory improvement. Metric: Recall Score |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the MS Quality of Life Assessment
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in MS Quality of Life Assessment Mental Health Composite score following treatment Period 1. MS Quality of Life Assessment is a standardized self-assessment questionnaire with scoring rules, where higher scores indicate mental health improvement. Metric: Mental Health Composite Score |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the MS Quality of Life Assessment Mental Health Composite
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in MS Quality of Life Assessment Mental Health Composite score following treatment Period 2. MS Quality of Life Assessment is a standardized self-assessment questionnaire with scoring rules, where higher scores indicate mental health improvement. Metric: Mental Health Composite Score |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Modified Fatigue Impact Scale
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change on the Modified Fatigue Impact Scale following treatment Period 1. Modified Fatigue Impact Scale is a standardized self-assessment questionnaire with scoring rules, where lower scores indicate fatigue improvement. Metric: Total Score |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Modified Fatigue Impact Scale
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change on the Modified Fatigue Impact Scale following treatment Period 2. Modified Fatigue Impact Scale is a standardized self-assessment questionnaire with scoring rules, where lower scores indicate fatigue improvement. Metric: Total Score |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Perceived Deficits Questionnaire
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change on the Perceived Deficits Questionnaire following treatment Period 1. The Perceived Deficits Questionnaire is a standardized self-assessment questionnaire with scoring rules, where lower scores indicate deficit improvement. Metric: Total Score |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 on the Perceived Deficits Questionnaire
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change on the Perceived Deficits Questionnaire following treatment Period 2. The Perceived Deficits Questionnaire is a standardized self-assessment questionnaire with scoring rules, where lower scores indicate deficit improvement. Metric: Total Score |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 in EEG P3 event-related potential on the Semantically Cued Inhibition Task
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in EEG P3 event-related potential amplitude on the Semantically Cued Inhibition Task following treatment Period 1. The Semantically Cued Inhibition Task is a measure of executive function under different semantic demand, where P3 event-related potential is measured at 300-600 ms post-stimulus onset. Metric: microvolts |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in EEG P3 event-related potential on the Semantically Cued Inhibition Task
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in EEG P3 event-related potential amplitude on the Semantically Cued Inhibition Task following treatment Period 2. The Semantically Cued Inhibition Task is a measure of executive function under different semantic demand, where P3 event-related potential is measured at 300-600 ms post-stimulus onset. Metric: microvolts |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 in EEG spectral power on the Semantically Cued Inhibition Task
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in EEG spectral power on the Semantically Cued Inhibition Task following treatment Period 1. The Semantically Cued Inhibition Task is a measure of executive function under different semantic demand, where spectral power is the sinusoidal decomposition of the EEG. Metric: decibels (dB) |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in EEG spectral power on the Semantically Cued Inhibition Task
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in EEG spectral power on the Semantically Cued Inhibition Task following treatment Period 2. The Semantically Cued Inhibition Task is a measure of executive function under different semantic demand, where spectral power is the sinusoidal decomposition of the EEG. Metric: decibels (dB) |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 in EEG late event-related potential on the Semantic Object Retrieval Task
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in EEG P3 event-related potential amplitude on the Semantic Object Retrieval Task following treatment Period 1. The Semantically Object Retrieval Task is a measure of object retrieval, where the late event-related potential is measured after 700 ms post-stimulus onset. Metric: microvolts |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in EEG late event-related potential on the Semantic Object Retrieval Task
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in EEG P3 event-related potential amplitude on the Semantic Object Retrieval Task following treatment Period 2. The Semantically Object Retrieval Task is a measure of object retrieval, where the late event-related potential is measured after 700 ms post-stimulus onset. Metric: microvolts |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Treatment group differences in change from baseline to 2-months post-treatment for Period1 in EEG spectral power on the Semantic Object Retrieval Task
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Evaluation of treatment arm differences in change in EEG spectral power on the Semantic Object Retrieval Task following treatment Period 1. The Semantically Object Retrieval Task is a measure of object retrieval, where spectral power is the sinusoidal decomposition of the EEG. Metric: decibels (dB) |
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
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Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in EEG spectral power on the Semantic Object Retrieval Task
Periodo de tiempo: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Evaluation of treatment arm differences in change in EEG spectral power on the Semantic Object Retrieval Task following treatment Period 2. The Semantically Object Retrieval Task is a measure of object retrieval, where spectral power is the sinusoidal decomposition of the EEG. Metric: decibels (dB) |
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Otros números de identificación del estudio
- IRB-26-579
- RG-2601-46141 (Otro número de subvención/financiamiento: National Multiple Sclerosis Society)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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