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Brain Stimulation
Brain State-Dependent PCMS for Stroke Recovery
Phase 1 & 2
Recruiting
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of stroke > 6 months ago
Presence of residual upper extremity hemiparesis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 hour after intervention
Awards & highlights
Study Summary
This trial will test whether specific time windows for combined brain and nerve stimulation are more effective than random time windows in improving post-stroke hand function.
Who is the study for?
This trial is for individuals who have had a stroke at least 6 months ago and now struggle with hand function due to upper extremity hemiparesis. They must be mentally fit (with a Mini Mental State Exam score over 24), willing to participate, able to consent, and have some movement in their affected arm but not full recovery (Fugl-Meyer score under 66).Check my eligibility
What is being tested?
The study tests whether delivering paired corticomotoneuronal stimulation (PCMS) during specific brain states improves hand function after stroke compared to random timing of PCMS. It aims to strengthen the neural pathways that control the hand by using combined brain and nerve stimulation.See study design
What are the potential side effects?
While side effects are not explicitly listed, potential risks may include discomfort or mild pain from nerve stimulation, headache or scalp discomfort from TMS, and possible temporary worsening of motor symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a stroke more than 6 months ago.
Select...
I have weakness in one of my arms.
Select...
I am willing to participate in the clinical trial.
Select...
My arm and hand movement is limited.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 hour after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 hour after intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum hand force output
Maximum hand muscle activation
Secondary outcome measures
Amplitude of motor evoked potentials
Time to complete the 9-hole peg test
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PCMS during brain states reflecting strong corticospinal transmissionExperimental Treatment1 Intervention
Group II: PCMS during random brain statesActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of Texas at AustinLead Sponsor
350 Previous Clinical Trials
80,939 Total Patients Enrolled
7 Trials studying Stroke
821 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your score on a mental exam is 24 or lower.You have medical reasons that make it unsafe for you to receive transcranial magnetic stimulation or peripheral nerve stimulation.My brain does not respond normally to a specific type of brain scan.I had a stroke more than 6 months ago.You scored higher than 24 on the Mini Mental State Exam.I have weakness in one of my arms.I have a neurological condition, but it's not a stroke.My arm and hand movements are fully functional.I am willing to participate in the clinical trial.My arm and hand movement is limited.You can show clear and dependable muscle responses when a magnetic pulse is used to stimulate the affected part of your brain.
Research Study Groups:
This trial has the following groups:- Group 1: PCMS during brain states reflecting strong corticospinal transmission
- Group 2: PCMS during random brain states
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many research subjects are being recruited for this investigation?
"That is accurate. The clinical trial in question, which was first announced on June 1st, 2022, remains open and actively recruiting patients. So far, 45 individuals have been recruited from a single site."
Answered by AI
Are there any enrollments still available for this research project?
"Yes, this clinical trial is still recruiting patients as of today. The listing was first posted on June 1st, 2022 and has been updated as recently as yesterday."
Answered by AI
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