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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 oktober 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Texas
      • Richardson, Texas, Verenigde Staten, 75080
        • Callier Clinical Researcher Center
        • Hoofdonderzoeker:
          • John Hart, Jr, MD
        • Contact:
        • Contact:
        • Onderonderzoeker:
          • Michael A Motes, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 64 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.

Andere namen:
  • HDtDCS
  • High Definition tDCS
  • Neuroelectrics Starstim tES
Sham-vergelijker: 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.
Apparaat: 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.

Andere namen:
  • schijnvertoning
  • nep tDCS
  • sham HDtDCS

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Category Fluency
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Auditory Verbal Learning Test Delayed Memory
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).

Medewerkers en onderzoekers

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Sponsor

The University of Texas at Dallas

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 september 2028

Studie voltooiing (Geschat)

1 september 2029

Studieregistratiedata

Eerst ingediend

27 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 oktober 2026

Eerst geplaatst (Werkelijk)

3 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

27 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB-26-579
  • RG-2601-46141 (Ander subsidie-/financieringsnummer: National Multiple Sclerosis Society)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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