About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
dementia of any type
epilepsy or other seizure disorders
severe traumatic brain injury
brain tumor
Trial design
Parallel
Treatments tested in this trial
Transcranial Direct Current Stimulation
DeviceTranscranial 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.
Sham transcranial direct current stimulation
DeviceSham 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.
Treatment groups
Trial outcomes
Primary outcomes
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
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
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
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
Secondary outcomes
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
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
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
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas at Dallas
Lead sponsor
University of Texas Southwestern Medical Center
Collaborator