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

Inclusion Criteria3

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 Criteria28

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

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.