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

RecruitingNot a drug-phase studyRelapsing MSNCT05958381

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Transcranial Direct Current Stimulation

Placebo

  • Sham transcranial direct current stimulation

What it measured

Main measures

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

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

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

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

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

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

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

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

Other measures (30)

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

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

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

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

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

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

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

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

    Thinking and memory
  • Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Span Backward

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

    Thinking and memory
  • Treatment group differences in change from Baseline to 1-week Post-Treatment on on the the Rey-Osterrieth Complex Figure Test

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

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

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

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

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

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

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

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

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

Who could take part

Relapsing MS · 18 to 65

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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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History

    1. Started

      Oct 2023

    2. Main results due

      Jun 2027

    3. Finished

      Jun 2027

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