ClinicalTrials.gg
RecruitingNCT05958381MS-HDtDCSUpdated Sep 15, 2026

Treatment of Cognitive Deficits in Multiple Sclerosis With High-Definition Transcranial Direct Current Stimulation

An interventional study of Transcranial Direct Current Stimulation and Sham transcranial direct current stimulation in Multiple Sclerosis, Relapsing-Remitting, sponsored by The University of Texas at Dallas. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by The University of Texas at Dallas · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) 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. Additionally, the study will examine the degree to which baseline assessments of cognition and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.

Read the detailed description

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 transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 10 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and 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 at baseline and two times following treatment competition (i.e., immediate and 2-months). For participants selected for the second round of intervention, primary outcome verbal memory measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected again two times immediately following completion of the last treatment and 2-months afterward.

02

Conditions studied

  • Multiple Sclerosis, Relapsing-Remitting

Keywords

  • transcranial direct current stimulation (tDCS)
  • multiple sclerosis
  • electroencephalography (EEG)
03

In context

Multiple Sclerosis, Relapsing-Remitting

618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.

This study's planned enrollment of 100 is above the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.

Browse Multiple Sclerosis, Relapsing-Remitting studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

º Diagnosed with relapsing-remitting multiple sclerosis (RRMS)

º Memory retrieval deficit based on neuropsychological testing done in our lab

º Must be fluent in speaking and reading English.

Exclusion criteria

Exclusion Criteria:

º Relapse or acute MS exacerbation or a course of in the two months preceding the testing

º Participants using benzodiazepines must have been on a stable dose for at least two months

º Potentially confounding psychological or neurological disorder, including:

  • dementia of any type
  • epilepsy or other seizure disorders
  • severe traumatic brain injury
  • brain tumor
  • present drug abuse
  • stroke
  • blood vessel abnormalities in the brain
  • Parkinson's disease
  • Huntington's disease

º inability to give

º cranial implants

º skull defects that affect tDCS administration

º use of medications that interact with or potentially interact with tDCS effects, including:

  • anti-convulsants
  • L-dopa
  • carbamazepine
  • sulpiride
  • pergolide
  • lorazepam
  • rivastigmine
  • dextromethorphan
  • D-cycloserine
  • flunarizine
  • ropinirole
  • stimulants (dextroamphetamine/amphetamine/modafinil/armodafinil) must be stopped during enrollment
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Transcranial direct current stimulation

    Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via 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. Other Names: tDCS 1 milliamp tDCS High definition tDCS High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10

    Device: Transcranial Direct Current Stimulation

  • Sham comparator
    Sham transcranial direct current stimulation

    Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of electrodes placed at Fz, F7, FP1, FP2, and F8 (International 10/10 System for electroencephalography electrode placement). All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.

    Device: Sham transcranial direct current stimulation

Interventions

  • DeviceTranscranial Direct Current Stimulation

    Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via 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: tDCS

  • DeviceSham transcranial direct current stimulation

    Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of electrodes placed at Fz, F7, FP1, FP2, and F8 (International 10/10 System for electroencephalography electrode placement) . All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.

    Also known as: Sham tDCS

06

What researchers measure

Primary outcomes

  1. Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency

    Evaluation of treatment group differences in change on Category Fluency from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  2. Treatment group differences in change from Baseline to 2-months Post-Treatment on Category Fluency

    Evaluation of treatment group differences in change on Category Fluency from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

  3. Treatment group differences in change from Baseline to 1-week Post-Treatment on COWAT

    Evaluation of treatment group differences in change on COWAT from baseline to 1-week post-treatment. Metric: Number of Correct Items Generated

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  4. Treatment group differences in change from Baseline to 2-months Post-Treatment on COWAT

    Evaluation of treatment group differences in change on COWAT from baseline to 2-months post-treatment. Metric: Number of Correct Items Generated

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

Secondary outcomes

  1. Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part A)

    Evaluation of treatment group differences in change on the Trail Making Test (Part A) from baseline to 1-week post-treatment. Metric: Time to Solution

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  2. Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part B)

    Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 1-week post-treatment. Metric: Time to Solution

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  3. Treatment group differences in change from Baseline to 1-week Post-Treatment on the Delis Kaplan Color Word Interference Test

    Evaluation of treatment group differences in change on the Delis Kaplan Color Word Interference Test from baseline to 1-week post-treatment. Metric: Time to Name Items

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  4. Treatment group differences in change from Baseline to 1-week Post-Treatment on on the Digit Span Forward

    Evaluation of treatment group differences in change on the on the Digit Span Forward from baseline to 1-week post treatment. Metric: Memory Span

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  5. Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Span Backward

    Evaluation of treatment group differences in change on the Digit Span Backward from baseline to 1-week post treatment. Metric: Memory Span

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  6. Treatment group differences in change from Baseline to 1-week Post-Treatment on on the the Rey-Osterrieth Complex Figure Test

    Evaluation of treatment group differences in change on the Rey-Osterrieth Complex Figure Test from baseline to 1-week post treatment. Metric: Score

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  7. Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Symbol Substitution Test

    Evaluation of treatment group differences in change on the on the the Digit Symbol Substitution Test from baseline to 1-week post treatment. Metric: Number of Items

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  8. Treatment group differences in change from Baseline to 1-week Post-Treatment on the Grooved Pegboard Test

    Evaluation of treatment group differences in change on the Grooved Pegboard Test from baseline to 1-week post-treatment. Metric: Completion Time

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  9. Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval Test

    Evaluation of treatment group differences in change on the Semantic Object Retrieval Test from baseline to 1-week post-treatment. Metric: Number of Correct Names Retrieved

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  10. Treatment group differences in change from Baseline to 1-week Post-Treatment on the Boston Naming Test

    Evaluation of treatment group differences in change on the Boston Naming Test from baseline to 1-week post-treatment. Metric: Number of Items Correctly Named

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  11. Treatment group differences in change from Baseline to 1-week Post-Treatment on the Auditory Verbal Learning Test

    Evaluation of treatment group differences in change on the Auditory Verbal Learning Test from baseline to 1-week post-treatment. Metric: Number of Items Remembered

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  12. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part A)

    Evaluation of treatment group differences in change on the Trail Making Test (Part A) from baseline to 2-months post-treatment. Metric: Time to Solution

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

  13. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part B)

    Evaluation of treatment group differences in change on the Trail Making Test (Part B) from baseline to 2-months post-treatment. Metric: Time to Solution

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

  14. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Delis Kaplan Color Word Interference Test

    Evaluation of treatment group differences in change on the Delis Kaplan Color Word Interference Test from baseline to 2-months post-treatment. Metric: Time to Name Items

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

  15. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Forward

    Evaluation of treatment group differences in change on the on the Digit Span Forward from baseline to 2-months post-treatment. Metric: Memory Span

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

  16. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Backward

    Evaluation of treatment group differences in change on the on the Digit Span Backward from baseline to 2-months post-treatment. Metric: Memory Span

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

  17. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Rey-Osterrieth Complex Figure Test

    Evaluation of treatment group differences in change on the on the Rey-Osterrieth Complex Figure Test from baseline to 2-months post-treatment. Metric: Score

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

  18. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Symbol Substitution Test

    Evaluation of treatment group differences in change on the on the the Digit Symbol Substitution Test from baseline to 2-months post treatment. Metric: Number of Items

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

  19. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Grooved Pegboard Test

    Evaluation of treatment group differences in change on the Grooved Pegboard Test from baseline to 2-months post-treatment. Metric: Completion Time

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

  20. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval Test

    Evaluation of treatment group differences in change on the Semantic Object Retrieval Test from baseline to 2-months post-treatment. Metric: Number of Correct Names Retrieved

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

  21. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Boston Naming Test

    Evaluation of treatment group differences in change on the Boston Naming Test from baseline to 2-months post-treatment. Metric: Number of Items Correctly Named

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

  22. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Auditory Verbal Learning Test

    Evaluation of treatment group differences in change on the Auditory Verbal Learning Test from baseline to 2-months post-treatment. Metric: Number of Items Remembered

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

  23. Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Inhibition Task EEG spectral power

    Evaluation of treatment group differences in change on the Semantic Inhibition Task EEG from baseline to 1-week post-treatment. Metric: EEG spectral (theta) power

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 2-months Post-Treatment

  24. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Inhibition Task EEG spectral power

    Evaluation of treatment group differences in change on the Semantic Inhibition Task EEG from baseline to 2-months post-treatment. Metric: EEG spectral (theta) power

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

  25. Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Inhibition Task EEG Event-Related Potential (N2/P3)

    Evaluation of treatment group differences in change on the Semantic Inhibition Task EEG from baseline to 1-week post-treatment. Metric: EEG N2/P3 event-related potential amplitude

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  26. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Inhibition Task EEG Event-Related Potential (N2/P3)

    Evaluation of treatment group differences in change on the Semantic Inhibition Task EEG from baseline to 2-months post-treatment. Metric: EEG N2/P3 event-related potential amplitude

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

  27. Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval EEG spectral power

    Evaluation of treatment group differences in change on the Semantic Object Retrieval EEG from baseline to 1-week post-treatment. Metric: EEG spectral (theta) power

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  28. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval EEG spectral power

    Evaluation of treatment group differences in change on the Semantic Object Retrieval EEG from baseline to 2-months post-treatment. Metric: EEG event-related potential amplitude

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 1-week Post-Treatment

  29. Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval EEG event-related potential

    Evaluation of treatment group differences in change on the Semantic Object Retrieval EEG from baseline to 1-week post-treatment. Metric: EEG late-onset (750 ms) event-related potential

    Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

  30. Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval EEG event-related potential

    Evaluation of treatment group differences in change on the Semantic Object Retrieval EEG from baseline to 2-months post-treatment. Metric: EEG late-onset (750 ms) event-related potential

    Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05958381
Lead sponsor
The University of Texas at Dallas
Responsible party
John Hart, Jr. (Professor, The University of Texas at Dallas) — Principal investigator
First posted
Jul 24, 2023
Start date
Oct 18, 2023
Primary completion
Jun 29, 2027 (estimated)
Completion
Jun 29, 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

Ashna Adhikari, MS
Contact
Ashna.Adhikari@UTDallas.edu
972-833-3161
Jill Ritter, BS
Contact
jill.ritter@utdallas.edu
972-833-3161
John Hart, Jr, MD
principal investigator · The University of Texas at Dallas

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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