An interventional study of High Definition transcranial Direct Current Stimulation and Sham High Definition transcranial Direct Current Stimulation in Multiple Sclerosis and Relapsing-remitting Multiple Sclerosis (RRMS), sponsored by The University of Texas at Dallas. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by The University of Texas at Dallas · Not applicable, Interventional, and Treatment
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.
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).
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's planned enrollment of 80 is above the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →The University of Texas at Dallas is the lead sponsor of 60 studies on the registry; 19 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
Compared within Multiple Sclerosis, Relapsing-Remitting, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Multiple Sclerosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
Device: Sham 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.
Also known as: HDtDCS, High Definition tDCS, Neuroelectrics Starstim tES
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.
Also known as: sham, sham tDCS, sham HDtDCS
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Category Fluency
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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 Auditory Verbal Learning Test Delayed Memory
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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)
Time frame: 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
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)
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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)
Time frame: 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
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)
Time frame: The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
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Multiple Sclerosis, Relapsing-Remitting →
The University of Texas at Dallas