Your session is about to expire
← Back to Search
Behavioural Intervention
TMS + Exercise for Post-Stroke Headache
Phase 1
Recruiting
Led By Chen Lin, 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
Minimum pain intensity of 30 on the Mechanical Visual Analogue Scale on average with pain symptoms.
Ability to walk or tolerate recumbent cycle ergometry for 10 mins without assistance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 12 weeks
Awards & highlights
Study Summary
This trial will test if a combination of exercise and transcranial magnetic stimulation is safe and effective in treating chronic post-stroke pain.
Who is the study for?
This trial is for US military veterans who've had a stroke at least 3 months ago and suffer from chronic pain after the stroke. They must be able to do some exercise, not be pregnant or planning pregnancy, have stable pain medication use, and pass an initial exercise test. People with seizure history, severe cognitive issues, certain mental health conditions, substance abuse problems or those unable to attend sessions are excluded.Check my eligibility
What is being tested?
The study tests whether combining repetitive transcranial magnetic stimulation (rTMS), which stimulates the brain using electromagnetic induction, with exercise can safely reduce post-stroke pain more effectively than sham rTMS plus exercise.See study design
What are the potential side effects?
Potential side effects of rTMS may include headache or scalp discomfort at the site of stimulation, lightheadedness, seizures (though rare), and hearing loss if ear protection isn't used during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My average pain level is at least 30 on a scale.
Select...
I can walk or use a stationary bike for 10 minutes without help.
Select...
It has been over 3 months since my stroke and my condition is stable.
Select...
I am using birth control and am not pregnant or planning to become pregnant or breastfeed during the study.
Select...
My average pain level is at least 30 on a scale.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual Analogue Scale for Pain
Other outcome measures
modified Rankin Scale
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: active rTMS+ExerciseActive Control1 Intervention
active rTMS
Group II: sham rTMS+ExercisePlacebo Group1 Intervention
sham rTMS
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,305,252 Total Patients Enrolled
Chen Lin, MDPrincipal InvestigatorBirmingham VA Medical Center, Birmingham, AL
2 Previous Clinical Trials
65 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with bipolar disorder I, schizophrenia, schizoaffective disorder, or OCD.I was independent in daily activities before my stroke.I might not be able to attend all sessions due to moving or transportation issues.I have a history of seizures.You are seeking legal compensation for a mental health disorder.I am a 19-year-old veteran of the US military.My average pain level is at least 30 on a scale.I have a neurological condition from a stroke that affects my ability to follow instructions.My headache has lasted more than 3 months after my stroke stabilized.You have health conditions that make it unsafe for you to have a TMS or MRI scan.I can walk or use a stationary bike for 10 minutes without help.You have been diagnosed with a moderate or severe substance use disorder (except for caffeine and nicotine) in the last 3 months.My pain medication has not changed in the last month.It has been over 3 months since my stroke and my condition is stable.You have finished a thorough exercise test, including a heart monitoring and a test to measure how your body uses energy during exercise.You have a high risk of trying to harm yourself or have had strong thoughts about harming yourself in the past 3 months.I am using birth control and am not pregnant or planning to become pregnant or breastfeed during the study.You are currently participating in another study for pain or stroke treatment.You have significant problems with memory and thinking, as shown by a specific test.I have ongoing headaches after a stroke that aren't caused by another condition.My average pain level is at least 30 on a scale.
Research Study Groups:
This trial has the following groups:- Group 1: sham rTMS+Exercise
- Group 2: active rTMS+Exercise
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.
Is the combination of active rTMS and exercise beneficial to patients without any adverse effects?
"Our analysts at Power ranked active rTMS+Exercise as a 1 on the safety scale, as this is an early-phase trial and there are limited data indicating its efficacy or potential risks."
Answered by AI
How many participants are currently signed up for the clinical trial?
"Affirmative. According to the information provided on clinicaltrials.gov, this study is actively recruiting participants who have met the inclusion criteria. The trial was first posted January 14th 2022 and most recently revised on January 18th 2022, with 32 patients being sought from 1 medical centre."
Answered by AI
Does this experiment currently need participants?
"The trial is open to applicants, as evidenced by the latest update on clinicaltrials.gov dated January 18th 2022. The initial post was made on January 14th of the same year."
Answered by AI
Who else is applying?
What site did they apply to?
Birmingham VA Medical Center, Birmingham, AL
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger