Multiple Sclerosis Clinical Trial
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.
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.
Diagnosed with relapsing-remitting multiple sclerosis (RRMS) with a memory retrieval deficit based on neuropsychological testing criteria and the last relapse being at least 6 months prior to enrollment. RRMS consists of fluctuating periods of worsening symptoms and recovery. Must be fluent in speaking and reading English.
Eligible MS patients will be free of significant medical issues or substance abuse. Exclusion criteria are a relapse or acute MS exacerbation or a course of steroids in the two months preceding the testing. Participants using benzodiazepines must have been on a stable dose for at least two months. Before enrollment, aspects of the study protocol will be reviewed with each participant and informed written consent will be obtained.
Exclusion criteria include: a potentially confounding psychological or neurological disorder, including, dementia of any type, epilepsy or other seizure disorders; severe traumatic brain injury (based on the Ohio Stated TBI Identification Method); brain tumor; present drug abuse; stroke; blood vessel abnormalities in the brain; Parkinson's disease; or Huntington's disease. Participants being seen in the PIs clinics will assess these issues as a part of the standard clinical assessment. However, all potential participants also will complete a self-reported history during the assessment process for the study to determine to further assess and document whether exclusion criteria are present.
Additionally, exclusion criteria include inability to give informed consent; cranial implants or skull defects that affect tDCS administration; and 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, or citalopram
Patients that are on stimulants (dextroamphetamine/amphetamine) or modafinil/armodafinil can be considered for inclusion in the study if they agree to end use prior to HD tDCS treatment in Phase 1 and Phase 2 (2 days prior for stimulants; 3 days prior for modafinil/armodafinil) followed by reinstitution if desired after the final treatment. Additionally, we will delay doing immediate testing following the 10th session for 3 or more days if they decide to resume taking any of these medications after the 10th session.
Additionally, non-English speakers will be excluded because not all of the screening forms, questionnaires, and tests are available in languages other than English.
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