Multiple Sclerosis Clinical Trial

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

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.

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Full Description

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.

View Eligibility Criteria

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
citalopram
stimulants (dextroamphetamine/amphetamine/modafinil/armodafinil) must be stopped during enrollment

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT05958381

Recruitment Status:

Recruiting

Sponsor:

The University of Texas at Dallas

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There is 1 Location for this study

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The University of Texas at Dallas
Richardson Texas, 75080, United States More Info
Jill Ritter, BS
Contact
972-833-3161
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT05958381

Recruitment Status:

Recruiting

Sponsor:


The University of Texas at Dallas

How clear is this clinincal trial information?

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