Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

October 8, 2025 updated by: Yi-Ling Kuo, PT, PhD, State University of New York - Upstate Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wrist actigraphy - physical activity level
Time Frame: baseline, immediately post-treatment (completion of rTMS)
Kinematic assessments by the wrist actigraphy will be worn to measure physical activity level.
baseline, immediately post-treatment (completion of rTMS)
Neurophysiological measures by TMS
Time Frame: baseline, immediately post-treatment (completion of rTMS)
Neurophysiology will be measured by TMS to indicate changes in brain function.
baseline, immediately post-treatment (completion of rTMS)
Gene expression
Time Frame: baseline, immediately post-treatment (completion of rTMS)
Peripheral blood will be collected to measure mRNA to impute gene expression.
baseline, immediately post-treatment (completion of rTMS)
Daily headache diary
Time Frame: daily documentation throughout the treatment course (4 weeks)
Composite headache score will be calculated as average intensity (NRS) × average frequency (episode/day) × average duration (hours/episode).
daily documentation throughout the treatment course (4 weeks)
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
The HIT-6 will be used to assess the impact of headaches on one's ability to function in occupational and social lives. On a scale of 36 to 78, higher numbers indicate worse outcomes.
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
The change in global post-concussion symptoms will be measured by the PCSS. On a scale of 1 to 5, higher numbers indicate worse outcomes.
baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up
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
The PROMIS questionnaires with subsections of 1) pain interference, 2) pain behavior will be used as patient-reported outcomes of pain and sleep. For all subsections, on a scale of 1 to 5, higher numbers indicate worse outcomes.
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)
Peripheral blood will be collected to measure protein expression
baseline, immediately post-treatment (completion of rTMS)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wrist actigraphy - sleep quality
Time Frame: baseline, immediately post-treatment (completion of rTMS)
Kinematic assessments by the wrist actigraphy will be worn to measure sleep quality.
baseline, immediately post-treatment (completion of rTMS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Upstate Medical University

Investigators

  • Principal Investigator: Yi-Ling Kuo, PT, PhD, State University of New York - Upstate Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2023

Primary Completion (Estimated)

October 23, 2026

Study Completion (Estimated)

October 23, 2027

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Estimated)

October 10, 2025

Last Update Submitted That Met QC Criteria

October 8, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1825424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study investigators will make the de-identified data available to users for research purposes. Sharing and modification rights of the study data will be determined for individual users by the Principal Investigator.

IPD Sharing Time Frame

Data will be available no later than upon the publication of the final dataset.

IPD Sharing Access Criteria

Study personnel on the list approved by the Institutional Review Board and researchers outside of this project as approved by the Principal Investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Headache

Clinical Trials on Repetitive Transcranial Magnetic Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe