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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
MS-HDtDCS Trial 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.Check my eligibility
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.See study design
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.
MS-HDtDCS Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreSide effects data
From 2021 Phase 2 & 3 trial • 160 Patients • NCT024834682%
Car accident
2%
skin irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
tDCS (Active)
tDCS (Sham)
MS-HDtDCS 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
58 Previous Clinical Trials
106,155 Total Patients Enrolled
1 Trials studying Multiple Sclerosis
30 Patients Enrolled for Multiple Sclerosis
University of Texas Southwestern Medical CenterOTHER
1,048 Previous Clinical Trials
1,053,655 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medication that could affect the study treatment.I have been taking the same dose of benzodiazepines for at least two months.I do not have any major brain-related health issues like dementia, epilepsy, or drug abuse.I am unable to understand and agree to the study's details.I have been diagnosed with relapsing-remitting multiple sclerosis.I have had a recent MS flare-up or steroid treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Transcranial direct current stimulation
- Group 2: Sham transcranial direct current stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this study still open?
"According to clinicaltrials.gov, the recruitment phase for this medical study has ended; its original posting date was July 30th 2023 and it was last updated on July 14th of that same year. However, there are other 1167 trials actively searching for patients at present time."
Answered by AI
Is it feasible for me to enroll in this experiment?
"Interested individuals must have a diagnosis of multiple sclerosis and be between the ages of 18-55 in order to qualiy for this medical trial. 80 participants are needed overall."
Answered by AI
Do participants in this experiment need to be a certain age?
"To be eligible for this study, applicants must between 18 and 55. Additionally, there are 69 trials specifically looking for pediatric patients and 977 designed to evaluate elderly individuals."
Answered by AI
What objectives does this research endeavor seek to fulfill?
"The primary focus of this clinical trial is the comparison between baseline and 1-week post-treatment Category Fluency scores. This data will be monitored over a 6 week period. Secondary objectives include assessing Trail Making Test (Part B) Time to Solution, Delis Kaplan Color Word Interference Test Time to Name Items, and Digit Span Forward Memory Span from Baseline to 1-week Post Treatment."
Answered by AI
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