Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

State University of New York - Upstate Medical University

Status and phase: Enrolling; Phase 1

Conditions: Mild Traumatic Brain Injury; Post-Concussion Symptoms; Brain Concussion; Headache

Treatments: Device: Sham Repetitive Transcranial Magnetic Stimulation; Device: Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06112093

1825424

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

Moderate-dose rTMS

Active Comparator group

Description:

12 sessions (1 session/day, 3 days/week for 4 weeks) of active rTMS

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

Sham rTMS

Sham Comparator group

Description:

12 sessions (1 session/day, 3 days/week for 4 weeks) of sham rTMS will be administered at the same location and duration as the Moderate-rTMS protocol. After the study is completed, participants will be offered an opportunity to receive active rTMS.

Treatment:

Device: Sham Repetitive Transcranial Magnetic Stimulation

High-dose rTMS

Active Comparator group

Description:

24 sessions (4 sessions/day, 3 days/week for 2 weeks) of active rTMS

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

Low-dose rTMS

Active Comparator group

Description:

6 sessions (1 session/day, 3 days/week for 2 weeks) of active rTMS

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation