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Procedure
TMS for Stroke
N/A
Recruiting
Led By Alexander Opitz, PhD
Research Sponsored by University of Minnesota
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 3 hours
Awards & highlights
Study Summary
This trial is studying the effects of TMS on motor cortex excitability in people who have had a stroke, and how the phase of the oscillatory rhythm (mu frequency) affects motor excitability in stroke patients.
Who is the study for?
This trial is for individuals who have experienced a stroke over 6 months ago and are facing motor difficulties. Participants must be able to communicate in English. Those with metal or electric implants, recent botulinum toxin treatments in the upper extremities, current pregnancy or breastfeeding, or a history of seizures cannot join.Check my eligibility
What is being tested?
The study is examining how transcranial magnetic stimulation (TMS) affects the excitability of the motor cortex in stroke survivors. It specifically looks at how different phases of brain wave rhythms influence this excitability.See study design
What are the potential side effects?
TMS may cause discomfort at the stimulation site, headache, lightheadedness, or twitching of facial muscles during application. Rarely it can induce seizures but is generally considered safe.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Motor evoked potentials (MEPs)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Participants Without Unilateral StrokeExperimental Treatment1 Intervention
Participants without self-reported unilateral stroke will take part in two experimental sessions:
First, for assessment of stroke characteristics, and second, the main transcranial magnetic stimulation experiment. During the first experimental session, the lack of unilateral stroke will be confirmed. In participants without stroke, TMS will be applied targeting at the intensity of up to 120% resting motor threshold both left and right hemisphere.
Group II: Participants With Unilateral StrokeExperimental Treatment1 Intervention
Participants with self-reported unilateral stroke will take part in two experimental sessions:
First, for assessment of stroke characteristics and MRI scan, and second, the main transcranial magnetic stimulation experiment. During the first experimental session, the unilateral stroke will be confirmed. In participants with stroke, TMS will be applied over the motor cortex on the affected and non-affected hemisphere at the intensity of up to 120% resting motor threshold.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial magnetic stimulation (TMS)
2013
Completed Phase 4
~510
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,703 Total Patients Enrolled
38 Trials studying Stroke
50,855 Patients Enrolled for Stroke
Alexander Opitz, PhDPrincipal InvestigatorUniversity of Minnesota Department of Biomedical Engineering
3 Previous Clinical Trials
82 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a seizure without a known cause.I have had a stroke over 6 months ago and still experience movement problems.You have a metal or electric implant in your head, neck, or chest.I have received botulinum toxin treatment in my arm or hand in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Participants Without Unilateral Stroke
- Group 2: Participants With Unilateral Stroke
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.
Are there open slots for volunteers in this experiment?
"According to the clinicaltrials.gov portal, recruitment for this medical experiment is currently in progress. This trial was first published on October 1st 2021 and has been edited as recently as March 1st 2022."
Answered by AI
What is the upper limit for enrollment in this research project?
"Affirmative. According to clinicaltrials.gov, this research initiative was first posted on October 1st 2021 and requires 72 participants from one location; the trial is actively recruiting at present."
Answered by AI
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