RecruitingNot ApplicableNCT05958381

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

Sponsor

The University of Texas at Dallas

Enrollment

100 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis, Relapsing-Remitting

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a non-invasive brain stimulation technique called tDCS (transcranial direct current stimulation — a mild electrical current applied to the scalp) can improve memory problems in people with relapsing-remitting multiple sclerosis (MS). **You may be eligible if...** - You have a confirmed diagnosis of relapsing-remitting MS - You have memory retrieval problems detected on neuropsychological testing - You are fluent in English (speaking and reading) **You may NOT be eligible if...** - You had an MS relapse or took steroids in the past 2 months - You have dementia, epilepsy, Parkinson's disease, brain tumor, stroke, or other significant neurological condition - You have metal implants in your head or skull defects that prevent tDCS - You currently use certain medications including anti-seizure drugs, L-dopa, carbamazepine, or stimulants like amphetamines (unless able to pause them during the study) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscranial Direct Current Stimulation

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.

DEVICESham transcranial direct current stimulation

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.