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Brain Stimulation for Post-Stroke Gait Rehabilitation
Phase 2
Waitlist Available
Led By Svetlana Pundik, MD
Research Sponsored by VA Office of Research and Development
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 at 1-4 days after completion of 10-session intervention protocol
Awards & highlights
Study Summary
This trial will test whether a brain stimulation treatment called transcranial Direct Current Stimulation (tDCS) can help improve walking abilities in stroke survivors when used alongside physical therapy.
Who is the study for?
This trial is for American Veterans and other individuals who have had a stroke at least 6 months ago, resulting in walking difficulties. They must be medically stable, able to endure the study's demands, and capable of giving informed consent. Participants should have some movement in their affected ankle but not full normal function.Check my eligibility
What is being tested?
The study is examining whether adding brain stimulation called transcranial Direct Current Stimulation (tDCS) to physical therapy improves walking more than just physical therapy alone. Some participants will receive real tDCS while others get a sham treatment without any active stimulation.See study design
What are the potential side effects?
Possible side effects of tDCS may include mild discomfort or itching under the electrode during stimulation, headache, fatigue, nausea or dizziness. These are generally temporary and considered minor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1-4 days after completion of 10-session intervention protocol
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1-4 days after completion of 10-session intervention protocol
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Gait Speed from baseline
Other outcome measures
Change in Motor Evoked Potentials from baseline
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active tDCSActive Control1 Intervention
active tDCS plus gait training
Group II: Sham tDCSPlacebo Group1 Intervention
sham tDCS plus gait training
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,558 Total Patients Enrolled
83 Trials studying Stroke
6,673 Patients Enrolled for Stroke
Svetlana Pundik, MDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH
3 Previous Clinical Trials
120 Total Patients Enrolled
1 Trials studying Stroke
20 Patients Enrolled for Stroke
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no health conditions that prevent me from using rTMS therapy.I cannot have an MRI due to certain health reasons.I can handle the demands of this study.My leg's movement score is over 15 and I can move my ankle upwards.I cannot move my ankle upwards even a little.I can fully bend my knee and ankle without difficulty.I have had a stroke that affected both sides of my body.I had my first stroke more than 6 months ago and am stable.I am mentally capable of understanding and agreeing to participate in this study.I cannot complete treadmill exercises due to low stamina.
Research Study Groups:
This trial has the following groups:- Group 1: Active tDCS
- Group 2: Sham tDCS
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.
What is the current capacity for recruitment in this research study?
"Affirmative. Clinicaltrials.gov attests to this trial's recruitment status; initially posted on September 13th 2018 and most recently updated October 5th 2022, the study is seeking 50 participants from a single site."
Answered by AI
Are there opportunities to enroll in this experiment currently?
"Per the clinicaltrials.gov listing, recruitment is ongoing for this medical trial that was initially published on September 13th 2018 and then modified October 5th 2022."
Answered by AI
What hazards have been documented with regards to Active tDCS?
"While Active tdcs shows promise in terms of safety, there is currently no evidence that supports its efficacy. Our team at Power therefore assign it a score of 2 on the 1-3 scale."
Answered by AI
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