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Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial (MS-LIFG-HDtDCS)

27 ottobre 2026 aggiornato da: John Hart, Jr., The University of Texas at Dallas

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Texas
      • Richardson, Texas, Stati Uniti, 75080
        • Callier Clinical Researcher Center
        • Investigatore principale:
          • John Hart, Jr, MD
        • Contatto:
        • Contatto:
        • Sub-investigatore:
          • Michael A Motes, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 64 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.

Altri nomi:
  • HDtDCS
  • High Definition tDCS
  • Neuroelectrics Starstim tES
Comparatore fittizio: 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.
Dispositivo: 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.

Altri nomi:
  • finto
  • falso tDCS
  • sham HDtDCS

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Category Fluency
Lasso di tempo: 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).

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).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Category Fluency
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Verbal Fluency
Lasso di tempo: 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).

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).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Verbal Fluency
Lasso di tempo: 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).

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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Auditory Verbal Learning Test Delayed Memory
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 Picture Description Test Words Per Minute
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Period Picture Description Test Main Concepts Score
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Period Picture Description Test Core Lexicon Score
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Boston Naming Test Score
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Semantic Object Retrieval Test
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Delis-Kaplan Executive Function System Color Word Interference-Switching Test
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Trail Making Test: Part A
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on Trail Making Test: Part B
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Digit Span Forward
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Digit Span Backward
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Wisconsin Card Sort Categories Achieved
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in Judgment of Line Orientation
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Grooved Pegboard Test
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Paced Auditory Serial Addition Test
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Brief Visual Memory Test
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Digit Symbol Substitution Test
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Rey-Osterrieth Complex Figure Test
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the MS Quality of Life Assessment
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Modified Fatigue Impact Scale
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 on the Perceived Deficits Questionnaire
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in EEG spectral power on the Semantically Cued Inhibition Task
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 in EEG spectral power on the Semantic Object Retrieval Task
Lasso di tempo: 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).

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).
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
Lasso di tempo: 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).

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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The University of Texas at Dallas

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 settembre 2028

Completamento dello studio (Stimato)

1 settembre 2029

Date di iscrizione allo studio

Primo inviato

27 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 ottobre 2026

Primo Inserito (Effettivo)

3 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB-26-579
  • RG-2601-46141 (Altro numero di sovvenzione/finanziamento: National Multiple Sclerosis Society)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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