Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches
Purpose
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.
Conditions
- Brain Concussion
- Mild Traumatic Brain Injury
- Headache
- Post-Concussion Symptoms
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 18 - 55 years old who were actively working prior to mTBI - 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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- The Active rTMS group will receive 12 sessions (3 sessions/week) of rTMS and the Sham rTMS group will receive rTMS from a sham coil at the same location and duration as the Active rTMS group.
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
- Masking Description
- The participants will be blind and randomly assigned to either the Active rTMS or the Sham rTMS group.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Repetitive transcranial magnetic stimulation (rTMS) |
12 sessions (3 sessions/week) of active rTMS at the left motor cortex to upregulate brain excitability and reduce headaches and post-concussion symptoms. |
|
|
Sham Comparator Sham rTMS |
12 sessions (3 sessions/week) of sham rTMS will be administered at the same location and duration as the active rTMS but will not modulate brain function. After the study is completed, participants will be offered an opportunity to receive active rTMS. |
|
Recruiting Locations
SUNY Upstate Medical University
Syracuse, New York 13210
Syracuse, New York 13210
More Details
- NCT ID
- NCT06112093
- Status
- Recruiting
- Sponsor
- State University of New York - Upstate Medical University