Print

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

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Moderate-dose rTMS 		12 sessions (1 session/day, 3 days/week for 4 weeks) of active rTMS
  • Device: Repetitive Transcranial Magnetic Stimulation
    rTMS will be used to regulate the motor cortex to reduce headaches and post-concussion symptoms.
    Other names:
    • Transcranial magnetic stimulation
Sham Comparator
Sham rTMS 		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.
  • Device: Sham Repetitive Transcranial Magnetic Stimulation
    Sham rTMS will be delivered by a sham coil as a comparator to the (active) rTMS. Sham rTMS will not change the brain function of the control group.
Active Comparator
High-dose rTMS 		24 sessions (4 sessions/day, 3 days/week for 2 weeks) of active rTMS
  • Device: Repetitive Transcranial Magnetic Stimulation
    rTMS will be used to regulate the motor cortex to reduce headaches and post-concussion symptoms.
    Other names:
    • Transcranial magnetic stimulation
Active Comparator
Low-dose rTMS 		6 sessions (1 session/day, 3 days/week for 2 weeks) of active rTMS
  • Device: Repetitive Transcranial Magnetic Stimulation
    rTMS will be used to regulate the motor cortex to reduce headaches and post-concussion symptoms.
    Other names:
    • Transcranial magnetic stimulation

Recruiting Locations

SUNY Upstate Medical University
Syracuse 5140405, New York 5128638 13210
Contact:
Yi-Ling Kuo, PT, PhD
3154646911
kuoy@upstate.edu

More Details

Status
Recruiting
Sponsor
State University of New York - Upstate Medical University

Study Contact

Yi-Ling Kuo, PT, PhD
3154646911
kuoy@upstate.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.