Actively Recruiting

Phase 1
Age: 18Years - 55Years
All Genders
Healthy Volunteers
ID06112093

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

Led by State University of New York - Upstate Medical University · Updated on 2025-10-10

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the long-term effects of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, on chronic headaches following mild traumatic brain injury (mTBI). This study aims to better identify biomarkers for diagnosis and prognosis while improving post-concussion symptoms and reducing the economic burden caused by delayed recovery. rTMS has been shown to reduce chronic headaches without the side effects commonly seen with medications. Participants will be assigned randomly to one of several groups receiving different doses of rTMS or a sham treatment that mimics the procedure without affecting brain function. The treatment schedules include 12 sessions over 4 weeks, 24 sessions over 2 weeks, or 6 sessions over 2 weeks, with sessions administered multiple times per week. After completing the study, participants initially in the sham group may have the opportunity to receive active rTMS. During the study, participants will keep a daily headache diary throughout the 4-week treatment and complete various assessments at baseline, immediately after treatment, and at 1-, 3-, and 6-month follow-ups. These assessments include patient-reported outcomes, protein and gene expression tests, neurophysiological measures, headache impact tests, concussion symptom scales, and physical activity and sleep quality monitoring using wrist actigraphy. The total involvement spans several months to monitor treatment effects and safety.

CONDITIONS

Brief Title

Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 to 55 years old
  • Mild traumatic brain injury with loss of consciousness less than 30 minutes, Glasgow Coma Scale between 13 and 15, or post-traumatic amnesia for 24 hours or less
  • Diagnosis of persistent post-traumatic headache according to International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria
  • Headache started within 7 days after head trauma
  • Headache persists for at least 3 months after head trauma despite standard care
  • Average headache intensity is 3 or higher on a 10-point scale on at least 3 days per week
  • No evidence of radiculopathy or peripheral neuropathy on electromyography or clinical evaluation
  • No evidence of other causes of headaches
Not Eligible

You will not qualify if you...

  • History of chronic headache diagnoses such as migraine, tension, or cluster headaches before mild traumatic brain injury
  • History of other neurological conditions with medications affecting the central nervous system
  • Contraindications to receiving transcranial magnetic stimulation such as history of epileptic seizures or having implants like a cardiac pacemaker or intracerebral vascular clip

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 2 to 4 weeks depending on assigned dosing schedule

Participants receive repetitive transcranial magnetic stimulation (rTMS) or sham rTMS to manage post-concussion headaches.

12 to 24 sessions, 3 days per week for 2 to 4 weeks

Follow-up

Duration - Up to 6 months

Participants are followed to assess headache symptoms and rehabilitation outcomes after treatment completion.

Visits at 1 month, 3 months, and 6 months post-treatment

Trial Site Locations

Total: 1 location

1

SUNY Upstate Medical University

Syracuse, New York, United States, 13210

Actively Recruiting

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Research Team

Y

Yi-Ling Kuo, PT, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

Post-Concussive Syndrome: a Focus on Post-Traumatic Headache and Related Cognitive, Psychiatric, and Sleep Issues.

Mia T Minen, Alexandra Boubour, Harjasleen Walia...

https://pubmed.ncbi.nlm.nih.gov/27709555

Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee.

P M Rossini, D Burke, R Chen...

https://pubmed.ncbi.nlm.nih.gov/25797650

Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines.

Simone Rossi, Andrea Antal, Sven Bestmann...

https://pubmed.ncbi.nlm.nih.gov/33243615

Using transcranial magnetic stimulation to quantify electrophysiological changes following concussive brain injury: a systematic review.

Brendan P Major, Mark A Rogers, Alan J Pearce

https://pubmed.ncbi.nlm.nih.gov/25603731