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Device
Transcranial Magnetic Stimulation for Stroke (CAM Trial)
N/A
Recruiting
Led By George F. Wittenberg, MD 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 45-90 years of age
Subcortical stroke (ex: internal capsule, deep white matter of posterior frontal lobe)
Must not have
Unable to give informed consent
Contractures or orthopedic problems limiting range of joint motion in the potential study arm or other impairments that would interfere with the study activities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediate (within 2 s after stimulation)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether TMS can help people with stroke regain movement.
Who is the study for?
This trial is for English-speaking adults aged 45-90 who've had a stroke at least 6 months ago, resulting in mild to moderate arm dysfunction. They must be medically stable and have no serious illnesses that would affect participation. People with visual loss, joint motion issues, or conditions preventing safe TMS/MRI use cannot join.
What is being tested?
The study uses Transcranial Magnetic Stimulation (TMS) while participants make movements with a robotic arm device to understand how the brain controls movement before and after a stroke and when it's most responsive to TMS.
What are the potential side effects?
TMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. It's generally considered safe but should be avoided by those with certain medical implants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 45 and 90 years old.
Select...
I had a stroke in a deep part of my brain.
Select...
I had a stroke that affects one side of my body and other causes have been ruled out.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to understand and agree to the study's procedures and risks.
Select...
I do not have joint or bone problems that limit my movement for study activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediate (within 2 s after stimulation)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate (within 2 s after stimulation)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Path length
Secondary study objectives
Accuracy
EMG
Times
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Reaching with TMSExperimental Treatment1 Intervention
All participants enrolled in this group will receive TMS while performing reaching movements in a robotic system.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Magnetic Stimulation
2017
Completed Phase 4
~730
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,649 Total Patients Enrolled
86 Trials studying Stroke
6,807 Patients Enrolled for Stroke
VA Pittsburgh Healthcare SystemFED
34 Previous Clinical Trials
13,150 Total Patients Enrolled
2 Trials studying Stroke
2 Patients Enrolled for Stroke
University of PittsburghOTHER
1,789 Previous Clinical Trials
16,359,547 Total Patients Enrolled
28 Trials studying Stroke
2,825 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 45 and 90 years old.I do not have a serious illness that would stop me from joining.You have a medical condition or implant that makes it unsafe for you to have TMS or MRI.I had a stroke more than 6 months ago.I had a stroke in a deep part of my brain.I am medically stable enough to join the study.I have some difficulty moving my arm.I had a stroke that affects one side of my body and other causes have been ruled out.I am unable to understand and agree to the study's procedures and risks.You have such bad eyesight that you wouldn't be able to see the patterns on the computer screen.I do not have joint or bone problems that limit my movement for study activities.
Research Study Groups:
This trial has the following groups:- Group 1: Reaching with TMS
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.
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