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Recruiting Phase 1 NCT06112093

Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

Trial Parameters

Condition Brain Concussion
Sponsor State University of New York - Upstate Medical University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age 55 Years
Start Date 2023-10-23
Completion 2026-10-23
Interventions
Repetitive Transcranial Magnetic StimulationSham Repetitive Transcranial Magnetic Stimulation

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.

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