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NCT Number: NCT05958381

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

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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at Dallas

Richardson, Texas, 75080, United States

Location status: Recruiting

Location contact

Jill Ritter, BS

CONTACT

[email protected]

972-833-3161

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

º Relapse or acute MS exacerbation or a course of steroids 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 informed consent

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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

Sham Transcranial Direct Current Stimulation

Device

Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal 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, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.

Other names: Sham tDCS

Primary outcomes

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

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

    Evaluation of treatment group differences in change on Category Fluency from baseline to 1-week post-treatment.

    Metric: Number of Correct Items Generated

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

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

    Evaluation of treatment group differences in change on Category Fluency from baseline to 2-months post-treatment.

    Metric: Number of Correct Items Generated

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

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

    Evaluation of treatment group differences in change on COWAT from baseline to 1-week post-treatment.

    Metric: Number of Correct Items Generated

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

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

    Evaluation of treatment group differences in change on COWAT from baseline to 2-months post-treatment.

    Metric: Number of Correct Items Generated

Secondary outcomes

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

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

    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

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

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

    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

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

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

    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

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

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

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

    Metric: Memory Span

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

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

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

    Metric: Memory Span

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

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

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

    Metric: Score

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

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

    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

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

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

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

    Metric: Completion Time

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

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

    Metric: Memory Span

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

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

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

    Metric: Memory Span

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

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

    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

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

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

    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

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

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

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

    Metric: Completion Time

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

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

    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

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

    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

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ashna Adhikari, MS

CONTACT

[email protected]

972-833-3161

Jill Ritter, BS

CONTACT

[email protected]

972-833-3161

Sponsors and collaborators

Lead sponsor

The University of Texas at Dallas

Other

Collaborators

  • University of Texas Southwestern Medical Center

Registry information

Acronym: MS-HDtDCS

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 24, 2023
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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