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

NCT05958381 · The University of Texas at Dallas
In plain English

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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.
Eligibility 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
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2023-10-18
Estimated completion: 2027-06-30
Last updated: 2025-08-14
Interventions
Device: Transcranial Direct Current StimulationDevice: Sham transcranial direct current stimulation
Primary outcomes
  • 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)
Sponsor
The University of Texas at Dallas · other
With: University of Texas Southwestern Medical Center
Contacts & investigators
ContactAshna Adhikari, MS · contact · Ashna.Adhikari@UTDallas.edu · 972-833-3161
ContactJill Ritter, BS · contact · jill.ritter@utdallas.edu · 972-833-3161
InvestigatorJohn Hart, Jr, MD · principal_investigator, The University of Texas at Dallas
All locations (1)
The University of Texas at DallasRecruiting
Richardson, Texas, United States
Treatment of Cognitive Deficits in Multiple Sclerosis With High-Definition Transcranial Direct Current Stimulation · TrialPath