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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
Awards & highlights

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 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
2%
skin irritation
2%
Car accident
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

The University of Texas at DallasLead Sponsor
62 Previous Clinical Trials
106,544 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
320 Patients Enrolled for Multiple Sclerosis
University of Texas Southwestern Medical CenterOTHER
1,072 Previous Clinical Trials
1,056,162 Total Patients Enrolled
15 Trials studying Multiple Sclerosis
51,594 Patients Enrolled for Multiple Sclerosis
John Hart, JrPrincipal InvestigatorUniversity of Texas at Dallas

Media Library

High-Definition Transcranial Direct Current Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05958381 — Phase 1 & 2
Multiple Sclerosis Research Study Groups: Transcranial direct current stimulation, Sham transcranial direct current stimulation
Multiple Sclerosis Clinical Trial 2023: High-Definition Transcranial Direct Current Stimulation Highlights & Side Effects. Trial Name: NCT05958381 — Phase 1 & 2
High-Definition Transcranial Direct Current Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05958381 — Phase 1 & 2
~66 spots leftby Jun 2026
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