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Noninvasive Brain Stimulation

Individualized tDCS for Motor Function Improvement

N/A
Recruiting
Led By Mark S George, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No history of epilepsy
Healthy volunteers or chronic stroke participants (at least 6 months prior to the study)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post-stimulation (20 minutes apart)
Awards & highlights

Study Summary

This trial will test whether a method of individually tailoring transcranial direct current stimulation (tDCS) can help to improve the stimulation's effects on behavior.

Who is the study for?
This trial is for right-handed individuals with no metal in their body, who can undergo TMS or MRI scans and have no history of epilepsy. It's open to healthy volunteers as well as those who had a stroke at least 6 months ago. Pregnant or breastfeeding individuals, those with substance abuse issues, current psychiatric treatments, or claustrophobia cannot participate.Check my eligibility
What is being tested?
The study tests different doses of transcranial direct current stimulation (tDCS) on brain activity: standard doses (2mA and 4mA), a sham dose that mimics tDCS without real effects, and an individualized dose tailored to the participant's response to potentially enhance motor function.See study design
What are the potential side effects?
tDCS may cause mild side effects such as tingling, itching or discomfort at the electrode site, fatigue, headache, nausea or dizziness. These are typically short-lived and vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never had epilepsy.
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I am a healthy volunteer or had a stroke at least 6 months ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post-stimulation (20 minutes apart)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-stimulation (20 minutes apart) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Motor Evoked Potential Variance
Difference in Motor Evoked Potential Amplitudes from 4mA and 2mA Stimulation

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Individualized stimulationExperimental Treatment1 Intervention
Group II: 4mA stimulationExperimental Treatment1 Intervention
Group III: 2mA stimulationExperimental Treatment1 Intervention
Group IV: Sham stimulationPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
930 Previous Clinical Trials
7,393,741 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,953 Previous Clinical Trials
2,660,410 Total Patients Enrolled
Mark S George, MDPrincipal InvestigatorMedical University of South Carolina
4 Previous Clinical Trials
137 Total Patients Enrolled

Media Library

2mA transcranial direct current stimulation (Noninvasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04742439 — N/A
Transcranial Direct Current Stimulation Research Study Groups: 4mA stimulation, Sham stimulation, Individualized stimulation, 2mA stimulation
Transcranial Direct Current Stimulation Clinical Trial 2023: 2mA transcranial direct current stimulation Highlights & Side Effects. Trial Name: NCT04742439 — N/A
2mA transcranial direct current stimulation (Noninvasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04742439 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly participants being sought for this clinical research?

"This research study is searching for subjects aged 18 and under 60 years old."

Answered by AI

Who meets the requirements to partake in this research?

"30 individuals of legal age and below 60 years old, who have tdcs, are sought for this study. Further requirements for participants include being in good health without any history of brain injury, epilepsy or psychiatric diagnoses; no metal inside the body; and not having any contraindications to TMS or MRI scanning."

Answered by AI

Is enrollment still available for this medical trial?

"While listed on clinicaltrials.gov, this medical trial is not in the process of recruiting patients. It was initially announced on April 1st 2022 and modified two months later; however, there are 6 other active trials currently open for enrollment."

Answered by AI
~47 spots leftby Dec 2024