TMS + Exercise for Post-Stroke Headache

Overseen By Chen Lin, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Seizures, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

9 Participants Needed

Trial Summary

What is the purpose of this trial?

There are over 7 million people living with stroke in the United States. Per year, approximately 17,000 Veterans are admitted to the VA for acute stroke. Chronic pain after stroke can occur between 10-50% of stroke survivors. Post-stroke pain (PSP) can lead to further complications in a stroke survivor's recovery. Exercise has improved PSP and associated symptoms such as mobility, fatigue, and quality of life. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive technique using electromagnetic induction for cortical neurostimulation. The use of rTMS has been explored shown to be effective in treating chronic PSP but is limited in effect duration. Our proposal will test the hypothesis that rTMS is feasible and safe to be paired with exercise. Additionally, the investigators believe a complementary effect can develop to enhance the neurostimulation duration of rTMS.

Research Team

Chen Lin, MD

Principal Investigator

Birmingham VA Medical Center, Birmingham, AL

Eligibility Criteria

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

I am a 19-year-old veteran of the US military.

My average pain level is at least 30 on a scale.

My headache has lasted more than 3 months after my stroke stabilized.

Exclusion Criteria

Persons imprisoned, of minor age, diagnosed with terminal illness, or require surrogate for consent

I have been diagnosed with bipolar disorder I, schizophrenia, schizoaffective disorder, or OCD.

I was independent in daily activities before my stroke.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either sham or active rTMS combined with exercise to improve post-stroke chronic pain

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Active rTMS and exercise
• Sham rTMS+Exercise

Trial Overview 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.

Participant Groups

Group I: active rTMS+Exercise Active Control 1 Intervention

active rTMS

Group II: sham rTMS+Exercise Placebo Group 1 Intervention

sham rTMS

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+