Transcranial magnetic stimulation to assess motor neurophysiology after acute stroke in the United States: Feasibility, lessons learned, and values for future research.
Yi-Ling Kuo, David J Lin, Isha Vora...
https://pubmed.ncbi.nlm.nih.gov/34890840/Actively Recruiting
Led by State University of New York - Upstate Medical University · Updated on 2025-10-10
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating the long-term effects of repetitive transcranial magnetic stimulation rTMS, a non-invasive brain stimulation technique, on chronic headaches following mild traumatic brain injury mTBI. This study aims to better identify biomarkers for diagnosis and prognosis while improving post-concussion symptoms and reducing the economic burden caused by delayed recovery. rTMS has been shown to reduce chronic headaches without the side effects commonly seen with medications. Participants will be assigned randomly to one of several groups receiving different doses of rTMS or a sham treatment that mimics the procedure without affecting brain function. The treatment schedules include 12 sessions over 4 weeks, 24 sessions over 2 weeks, or 6 sessions over 2 weeks, with sessions administered multiple times per week. After completing the study, participants initially in the sham group may have the opportunity to receive active rTMS. During the study, participants will keep a daily headache diary throughout the 4-week treatment and complete various assessments at baseline, immediately after treatment, and at 1-, 3-, and 6-month follow-ups. These assessments include patient-reported outcomes, protein and gene expression tests, neurophysiological measures, headache impact tests, concussion symptom scales, and physical activity and sleep quality monitoring using wrist actigraphy. The total involvement spans several months to monitor treatment effects and safety.
CONDITIONS
Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches
Y
Yi-Ling Kuo, PT, PhD
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State University of New York - Upstate Medical University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | High‑dose rTMS | Moderate‑dose rTMS | Low‑dose rTMS | Sham rTMS | Standard clinical management |
|---|---|---|---|---|---|
| What it is | High‑dose repetitive transcranial magnetic stimulation (rTMS) delivered per protocol | Moderate‑dose rTMS arm as defined in the trial protocol | Low‑dose rTMS arm | Sham rTMS delivered with a sham coil (no expected brain stimulation) | Routine management including headache diary and therapies tailored to headache type per clinical guidelines |
| Role in trial | One of the investigational active treatment arms | Investigational active treatment arm | Investigational active treatment arm | Control comparator arm (sham stimulation) | Typical current practice outside trial for post‑traumatic headache |
| Primary use | Evaluated to reduce persistent post‑traumatic headache | Evaluated to reduce persistent post‑traumatic headache | Evaluated to reduce persistent post‑traumatic headache | Serves as placebo control for efficacy evaluation | Reduce headache and improve function according to established headache management |
| How it is given or performed | rTMS delivered at highest intensity per protocol schedule | rTMS delivered at moderate intensity per protocol | rTMS delivered at lower intensity per protocol | Sham coil used to mimic rTMS without active stimulation | Diary and therapies delivered per clinical practice (e.g., medications, non‑pharmacologic measures) |
| Evidence status | Efficacy under evaluation in this trial; limited pilot data for rTMS in PTH exists | Efficacy under evaluation; similar pilot evidence applies | Efficacy under evaluation; similar preliminary support | Placebo control; not expected to provide therapeutic benefit | Has established evidence for headache management tailored to type, though specific to post‑traumatic headaches evidence is based on expert consensus |
| Important risks | Potential rTMS‑related risks as per safety guidelines | Potential rTMS‑related risks as per safety guidelines | Potential rTMS‑related risks as per safety guidelines | Minimal risk—sham stimulation | Risks vary by therapy; medication overuse headache is potential concern with frequent analgesic use |
| Important limitations | Dose‑response unknown; trial is early phase with small sample | Same as high‑dose arm | Same as high‑dose arm | Sham may have expectancy effects; blinding integrity may vary | No high‑quality trial evidence specifically for post‑traumatic headache; guidance largely consensus based |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 4 weeks depending on assigned dosing schedule
Participants receive repetitive transcranial magnetic stimulation (rTMS) or sham rTMS to manage post-concussion headaches.
12 to 24 sessions, 3 days per week for 2 to 4 weeks
Duration - Up to 6 months
Participants are followed to assess headache symptoms and rehabilitation outcomes after treatment completion.
Visits at 1 month, 3 months, and 6 months post-treatment
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Lead Sponsor