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Noninvasive Neuromodulation
Noninvasive Neuromodulation for Stroke Recovery
N/A
Waitlist Available
Led By Michael A. Urbin, PhD
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 12 months
Awards & highlights
Study Summary
This trial will study whether a new neuromodulation strategy can improve movement in stroke survivors with movement-related disability.
Who is the study for?
This trial is for adults aged 18-75 who have had their first stroke at least six months ago and are experiencing muscle weakness. It's not suitable for those with a history of seizures, metal implants, pacemakers, pregnancy, cognitive impairments that affect instruction following, or anyone over 300 lbs if MRI is needed.Check my eligibility
What is being tested?
The study tests a new noninvasive brain stimulation technique called PCMS to improve muscle control in stroke survivors. The goal is to see if this can strengthen the connection between brain cells controlling movement and spinal cord cells causing muscle movement.See study design
What are the potential side effects?
While specific side effects aren't listed for PCMS, similar neuromodulation treatments may cause discomfort at the stimulation site, headache, dizziness or nausea. Serious side effects are rare but could include seizure or changes in blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Physiology
Secondary outcome measures
Behavior
Trial Design
2Treatment groups
Experimental Treatment
Group I: PhysiologyExperimental Treatment1 Intervention
Different neural elements will be stimulated and evoked potentials will be recorded via electromyography. Metrics used to quantify evoked potentials will be used to infer changes in physiological functioning of the nervous system.
Group II: BehaviorExperimental Treatment1 Intervention
A visuomotor task will be performed and force signals will be recorded. Metrics used to quantify force signals will be used to infer changes in control processes governing movement.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Noninvasive neuromodulation via paired corticospinal-motoneuronal stimulation (PCMS)
2019
N/A
~70
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,537 Total Patients Enrolled
83 Trials studying Stroke
6,652 Patients Enrolled for Stroke
Michael A. Urbin, PhDPrincipal InvestigatorVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 Previous Clinical Trials
110 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have metal implants, a pacemaker, or other implanted devices.You have trouble staying awake or sitting still.You weigh more than 300 pounds and the MRI machine cannot accommodate your size.You have been diagnosed with a movement disorder other than stroke.You are between 18 and 75 years old.You have been diagnosed with your first stroke.You had a stroke at least six months ago.You have had seizures or epilepsy in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Physiology
- Group 2: Behavior
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.
What criteria have been set for individuals to join the clinical trial?
"This clinical trial is seeking 48 participants aged 18 to 75 who currently suffer from hemiparesis. Additional criteria for participation include a diagnosis of first-ever stroke, with the onset occurring at least six months prior to enrollment in the study."
Answered by AI
Is the recruiting process for this research experiment still ongoing?
"Clinicaltrials.gov divulges that this specific medical trial is recruiting participants, commencing from February 4th 2019 and last edited on November 2nd 2022."
Answered by AI
Is the enrollment of elderly participants greater than eighty-five currently accepted in this experiment?
"According to the prerequisites for this trial, applicants should be within 18 and 75 years old. Additionally, there are 99 trials suited for minors while 1,304 studies target individuals over 65."
Answered by AI
How many participants are being observed in this research initiative?
"Confirmative, the trial is indeed recruiting. As per clinicaltrials.gov, it was first posted on February 4th 2019 and its latest update occured on November 2nd 2022. The target recruitment pool consists of 48 individuals spread across two medical sites."
Answered by AI
Who else is applying?
What site did they apply to?
VA Pittsburgh Healthcare System University Drive Division
What portion of applicants met pre-screening criteria?
Did not meet criteria
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