NCT06112093 Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches
| NCT ID | NCT06112093 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | State University of New York - Upstate Medical University |
| Condition | Brain Concussion |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-10-23 |
| Primary Completion | 2026-10-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2023-10-23 with a primary completion date of 2026-10-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to examine the long-term effect of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, on chronic headaches following mild traumatic brain injury (mTBI). rTMS has been shown to be effective in reducing chronic headaches without side effects commonly seen in medications, such as sleepiness and addiction. This study uses rTMS to manage chronic headaches to improve post-concussion symptoms and reduce the economic burden due to delayed recovery. This project aims to better identify biomarkers for diagnosis and prognosis and maximize recovery from mTBI.
Eligibility Criteria
Inclusion Criteria: * 18 - 55 years old * mTBI with loss of consciousness for less than 30 min, initial Glasgow Coma Scale between 13 and 15, or post-traumatic amnesia for ≤ 24 hours * diagnosis of persistent post-traumatic headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria * headache develops within 7 days after head trauma * headache persists for \>=3 months after head trauma despite receiving standard care * average persistent headache intensity is \>= 3/10 of the numerical rating scale (NRS) on \>=3days/week * no evidence of radiculopathy or peripheral neuropathy on electromyography or clinical evaluation * no evidence of other possible causes of headaches Exclusion Criteria: * history of chronic headache diagnoses such as migraine, tension, or cluster headaches prior to the incidence of mTBI * history of other neurologic conditions with medications affecting the central nervous system * contraindications of receiving TMS (e.g., a history of epileptic seizure and having implants like a cardiac pacemaker or intracerebral vascular clip
Contact & Investigator
Yi-Ling Kuo, PT, PhD
PRINCIPAL INVESTIGATOR
State University of New York - Upstate Medical University
Frequently Asked Questions
Who can join the NCT06112093 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Brain Concussion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06112093 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06112093 currently recruiting?
Yes, NCT06112093 is actively recruiting participants. Contact the research team at kuoy@upstate.edu for enrollment information.
Where is the NCT06112093 trial being conducted?
This trial is being conducted at Syracuse, United States.
Who is sponsoring the NCT06112093 clinical trial?
NCT06112093 is sponsored by State University of New York - Upstate Medical University. The principal investigator is Yi-Ling Kuo, PT, PhD at State University of New York - Upstate Medical University. The trial plans to enroll 60 participants.