Status:
RECRUITING
Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches
Lead Sponsor:
State University of New York - Upstate Medical University
Conditions:
Brain Concussion
Mild Traumatic Brain Injury
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 23 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06112093
Start Date
October 23 2023
End Date
October 23 2027
Last Update
October 10 2025
Active Locations (1)
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1
SUNY Upstate Medical University
Syracuse, New York, United States, 13210