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Behavioural Intervention

Transcranial Direct Current Stimulation for Cognitive Impairment in Multiple Sclerosis (MS-HDtDCS Trial)

Phase 1 & 2

Recruiting

Led By John Hart, Jr

Research Sponsored by The University of Texas at Dallas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-month post-treatment

Summary

This trial will investigate how electric stimulation on the brain can help improve memory for MS patients, and how baseline cognition and history predict its effectiveness.

Who is the study for?

This trial is for individuals with relapsing-remitting multiple sclerosis who have trouble retrieving words. They must speak and read English well, not have had a recent MS episode or taken steroids, and can't be on certain medications like benzodiazepines unless stable for two months.

What is being tested?

The study tests if low-level electric brain stimulation (tDCS) improves word retrieval in MS patients. It compares real tDCS to sham (fake) treatment, measuring verbal skills before, during, after the treatment, and checks other cognitive abilities plus EEG readings.

What are the potential side effects?

Potential side effects of tDCS may include discomfort at the electrode site, itching or tingling during stimulation, headache, fatigue post-treatment. Serious risks are rare but could involve seizures or skin burns under electrodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-month post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-month post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome measures will be assessed as change over a period of 13 weeks: change from baseline to 2-month post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment group differences in change from Baseline to 1-week Post-Treatment on COWAT

Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency

Treatment group differences in change from Baseline to 2-months Post-Treatment on COWAT

+1 more

Secondary study objectives

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

Treatment group differences in change from Baseline to 1-week Post-Treatment on on the the Rey-Osterrieth Complex Figure Test

Treatment group differences in change from Baseline to 1-week Post-Treatment on the Auditory Verbal Learning Test

+27 more

Side effects data

From 2021 Phase 2 & 3 trial • 160 Patients • NCT02483468

skin irritation

Car accident

100%

80%

60%

40%

20%

Study treatment Arm

tDCS (Active)

tDCS (Sham)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Transcranial direct current stimulationExperimental Treatment1 Intervention

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

Group II: Sham transcranial direct current stimulationPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Direct Current Stimulation

2014

Completed Phase 3

~1100

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