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Behavioural Intervention

TMS + Exercise for Post-Stroke Headache

Phase 1
Waitlist Available
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
Must not have
Current diagnosis of DSM-5-defined bipolar disorder I, schizophrenia, schizoaffective disorder, or obsessive-compulsive disorder
Pre-stroke modified Rankin >2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 12 weeks

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.
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.
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 below
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My average pain level is at least 30 on a scale.
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I can walk or use a stationary bike for 10 minutes without help.
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It has been over 3 months since my stroke and my condition is stable.
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I am using birth control and am not pregnant or planning to become pregnant or breastfeed during the study.
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My average pain level is at least 30 on a scale.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with bipolar disorder I, schizophrenia, schizoaffective disorder, or OCD.
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I was independent in daily activities before my stroke.
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I have a history of seizures.
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I have a neurological condition from a stroke that affects my ability to follow instructions.
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I have ongoing headaches after a stroke that aren't caused by another condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Visual Analogue Scale for Pain
Other study objectives
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
1,664 Previous Clinical Trials
3,765,795 Total Patients Enrolled
Chen Lin, MDPrincipal InvestigatorBirmingham VA Medical Center, Birmingham, AL
2 Previous Clinical Trials
65 Total Patients Enrolled

Media Library

Active rTMS and exercise (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04672044 — Phase 1
Post-stroke headache Research Study Groups: sham rTMS+Exercise, active rTMS+Exercise
Post-stroke headache Clinical Trial 2023: Active rTMS and exercise Highlights & Side Effects. Trial Name: NCT04672044 — Phase 1
Active rTMS and exercise (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04672044 — Phase 1
~0 spots leftby Dec 2024
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