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

NCT05958381 | Recruiting DMC FDA Device

• 3 other identifiers: 23-521HT94252310618E04675.1a
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

transcranial direct current stimulation (tDCS); multiple sclerosis; electroencephalography (EEG)

Outcome Measures

Primary Outcomes (4)

• 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

  Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

• 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

  Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment

• 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

  Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

• 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

  Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment

Secondary Outcomes (30)

• Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part A)

  Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

• Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part B)

  Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

• Treatment group differences in change from Baseline to 1-week Post-Treatment on the Delis Kaplan Color Word Interference Test

  Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

• Treatment group differences in change from Baseline to 1-week Post-Treatment on on the Digit Span Forward

  Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

• Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Span Backward

  Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment

Study Arms (2)

Transcranial direct current stimulation

EXPERIMENTAL

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. Other Names: tDCS 1 milliamp tDCS High definition tDCS High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10

Device: Transcranial Direct Current Stimulation

Sham transcranial direct current stimulation

SHAM COMPARATOR

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.

Device: Sham transcranial direct current stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

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.

Also known as: tDCS

Transcranial direct current stimulation

Sham transcranial direct current stimulation DEVICE

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.

Also known as: Sham tDCS

Sham transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

The University of Texas at Dallas

Richardson, Texas, 75080, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• John Hart, Jr, MD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashna Adhikari, MS

CONTACT

972-833-3161; Ashna.Adhikari@UTDallas.edu

Jill Ritter, BS

CONTACT

972-833-3161; jill.ritter@utdallas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, assessors, and technicians interacting with participants will be blind to assigned conditions. The software for the transcranial direct current system allows for maintaining blinds when uploading and running protocols.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to 1 of 2 treatment arms: (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 15 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 15 sessions and will be and re-evaluated at immediate- and 2-months follow-up testing sessions.

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: October 18, 2023
• Primary Completion (Estimated): June 29, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (1)