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Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

This study is looking at how repetitive transcranial magnetic stimulation (rTMS) can help people with chronic headaches after a mild traumatic brain injury (mTBI). rTMS is a non-invasive (doesn't involve surgery or needles) brain stimulation technique. The study will compare active rTMS to a sham (inactive) rTMS device. Researchers want to see if rTMS can reduce headaches and other post-concussion symptoms long-term. You might be able to join if you are 18-55 years old, had a mild traumatic brain injury with specific symptoms, and developed headaches within 7 days of the injury. The study will measure headache frequency and patient-reported outcomes to see if the treatment is successful. The current status of this study is unclear.

Study design
This interventional study plans to enroll 60 participants. It compares active repetitive transcranial magnetic stimulation (rTMS) to a sham (inactive) rTMS device.
What's involved
You would have daily documentation of headaches throughout a 4-week treatment course. You would also complete surveys at baseline, immediately after treatment, and at 1, 3, and 6 months later.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after completing the rTMS treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06112093

Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

Recruiting
PHASE1Ages 18–55InterventionalTreatment
State University of New York - Upstate Medical University
~60 participants
Updated 2025-10-10 on ClinicalTrials.gov
What's tested:Repetitive Transcranial Magnetic StimulationSham Repetitive Transcranial Magnetic Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Daily headache diary
Measured over daily documentation throughout the treatment course (4 weeks)
+7 more outcomes measured

Conditions

Brain Concussion
Mild Traumatic Brain Injury
Headache
Post-Concussion Symptoms

Explore related trials

ConcussionHeadache

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Yi-Ling Kuo, PT, PhD · PRINCIPAL_INVESTIGATOR · State University of New York - Upstate Medical University

Who to contact

Yi-Ling Kuo, PT, PhD
[email protected]
3154646911
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Daily headache diarydaily 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).

  • Patient-Reported Outcomes Measurement Information System (PROMIS)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.

  • Protein expressionbaseline, immediately post-treatment (completion of rTMS)

    Peripheral blood will be collected to measure protein expression

  • Neurophysiological measures by TMSbaseline, immediately post-treatment (completion of rTMS)

    Neurophysiology will be measured by TMS to indicate changes in brain function.

  • Headache impact test 6 (HIT-6)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.

  • Post-Concussion Symptom Scale (PCSS)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.

  • Wrist actigraphy - physical activity levelbaseline, immediately post-treatment (completion of rTMS)

    Kinematic assessments by the wrist actigraphy will be worn to measure physical activity level.

  • Gene expressionbaseline, immediately post-treatment (completion of rTMS)

    Peripheral blood will be collected to measure mRNA to impute gene expression.