Using Repetitive Transcranial Magnetic Stimulation to Manage Headaches and Improve Rehabilitation Outcomes in Mild Traumatic Brain Injury: A Longitudinal Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:

• 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

Locations
United States
New York
SUNY Upstate Medical University
RECRUITING
Syracuse
Contact Information
Primary
Yi-Ling Kuo, PT, PhD
kuoy@upstate.edu
3154646911
Time Frame
Start Date: 2023-10-23
Estimated Completion Date: 2027-10-23
Participants
Target number of participants: 60
Treatments
Active_comparator: Moderate-dose rTMS
12 sessions (1 session/day, 3 days/week for 4 weeks) of active rTMS
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.
Active_comparator: High-dose rTMS
24 sessions (4 sessions/day, 3 days/week for 2 weeks) of active rTMS
Active_comparator: Low-dose rTMS
6 sessions (1 session/day, 3 days/week for 2 weeks) of active rTMS
Sponsors
Leads: State University of New York - Upstate Medical University

This content was sourced from clinicaltrials.gov