Recruiting
Phase 1

rTMS

Sponsor:

State University of New York - Upstate Medical University

Code:

NCT06112093

Conditions

Brain Concussion

Mild Traumatic Brain Injury

Headache

Post-Concussion Symptoms

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Repetitive Transcranial Magnetic Stimulation

Sham Repetitive Transcranial Magnetic Stimulation

Study Details

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 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

Study ID

NCT06112093

Start date

Oct 23, 2023

Status verified date

Oct, 2025

Completion date

Oct 23, 2027

Anticipated

Primary completion date

Oct 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Repetitive Transcranial Magnetic Stimulation

rTMS will be used to regulate the motor cortex to reduce headaches and post-concussion symptoms.

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.

Primary outcome measure

  • Daily headache diary [ Time Frame: daily documentation throughout the treatment course (4 weeks) ]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up ]
  • Protein expression [ Time Frame: baseline, immediately post-treatment (completion of rTMS) ]
  • Neurophysiological measures by TMS [ Time Frame: baseline, immediately post-treatment (completion of rTMS) ]
  • Headache impact test 6 (HIT-6) [ Time Frame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up ]
  • Post-Concussion Symptom Scale (PCSS) [ Time Frame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up ]
  • Wrist actigraphy - physical activity level [ Time Frame: baseline, immediately post-treatment (completion of rTMS) ]
  • Gene expression [ Time Frame: baseline, immediately post-treatment (completion of rTMS) ]

Central Contacts and Locations

Central contacts

Yi-Ling Kuo, PT, PhD

3154646911kuoy@upstate.edu

Locations

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Yi-Ling Kuo, PT, PhD

3154646911kuoy@upstate.edu

More Information

Sponsor

State University of New York - Upstate Medical University

Last update posted

Oct 10, 2025

Last verified

Oct, 2025

Keywords

  • Repetitive transcranial magnetic stimulation
  • Non-invasive brain stimulation
  • Neuromodulation
  • Chronic pain
  • Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York - Upstate Medical University on 2025-10-10.