TMS + Exercise for Post-Stroke Headache
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether combining repetitive transcranial magnetic stimulation (rTMS), a noninvasive brain stimulation technique, with exercise can reduce headaches after a stroke. The researchers aim to determine if pairing these treatments can extend benefits and improve recovery for stroke survivors with chronic pain. Veterans who experienced a stroke at least three months ago and have ongoing headaches may be suitable candidates, particularly if they can exercise independently for 10 minutes. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.
Do I need to stop my current medications for the trial?
The trial requires that your pain medication regimen be stable for 1 month before starting. It doesn't specify stopping other medications, so you may not need to stop them, but it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that repetitive transcranial magnetic stimulation (rTMS), combined with exercise, is being tested as a treatment for post-stroke pain. Studies on rTMS for other conditions have found it safe, though its effects may not last long. Early results suggest that adding exercise to rTMS might enhance its effectiveness.
Previous patients have generally tolerated rTMS well, with few serious side effects. Common side effects include mild headaches or a tingling sensation on the scalp, which usually resolve quickly. Exercise is well-known for its safety and benefits in improving movement and reducing pain.
As this is an early-phase trial, researchers are closely monitoring safety. However, the use of rTMS in other studies and its approval for other conditions provide some reassurance about its safety. Researchers will carefully monitor participants to ensure their safety throughout the trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of transcranial magnetic stimulation (rTMS) and exercise for post-stroke headache because it offers a novel approach that differs from typical pain management strategies, which often involve medications like analgesics or anti-inflammatory drugs. rTMS is unique because it uses magnetic fields to stimulate nerve cells in the brain, potentially reducing pain without the side effects associated with medication. Additionally, pairing rTMS with exercise could enhance rehabilitation by improving physical function and overall brain health. This combination has the potential to offer a more holistic and non-invasive treatment option, sparking interest in its ability to address both pain and recovery simultaneously.
What evidence suggests that this trial's treatments could be effective for post-stroke headache?
Research shows that exercise can improve pain, movement, and quality of life after a stroke. Studies have found that repetitive transcranial magnetic stimulation (rTMS), which uses magnets to stimulate the brain, aids stroke recovery. However, the benefits of rTMS alone might not last long. This trial will compare two approaches: active rTMS combined with exercise and sham rTMS combined with exercise. Early research suggests that combining active rTMS with exercise could extend the benefits, especially for post-stroke headaches. This combination is being studied to determine if it can enhance the effectiveness and duration of the treatment.12678
Who Is on the Research Team?
Chen Lin, MD
Principal Investigator
Birmingham VA Medical Center, Birmingham, AL
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either sham or active rTMS combined with exercise to improve post-stroke chronic pain
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Active rTMS and exercise
- Sham rTMS+Exercise
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor