Recruiting

tDCS

Sponsor:

The University of Texas at Dallas

Code:

NCT05958381

Conditions

Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Transcranial Direct Current Stimulation

Sham transcranial direct current stimulation

Study Details

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

Study ID

NCT05958381

Start date

Oct 18, 2023

Status verified date

Aug, 2026

Completion date

Jun 29, 2027

Anticipated

Primary completion date

Jun 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcranial 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.

Other Names:

tDCS

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

sham comparator: Sham 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.

Interventions

Transcranial 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.

Sham 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.

Primary outcome measure

  • Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment ]

Central Contacts and Locations

Central contacts

Ashna Adhikari, MS

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

Jill Ritter, BS

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

Locations

The University of Texas at Dallas

Recruiting

Richardson, Texas, United States, 75080

Contacts

Jill Ritter, BS

972-833-3161neurolab.memory@utdallas.edu

More Information

Sponsor

The University of Texas at Dallas

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas at Dallas on 2026-08-14.