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NCT Number: NCT06112093

Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

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.

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Key information

Conditions

Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Chronic Pain Craniocerebral Trauma Head Injuries, Closed Headache Mild Traumatic Brain Injury Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Post-Concussion Symptoms Post-Concussion Syndrome Signs and Symptoms Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location status: Recruiting

Location contact

Yi-Ling Kuo, PT, PhD

CONTACT

[email protected]

3154646911

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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

Other names: Transcranial magnetic stimulation

Sham repetitive transcranial magnetic stimulation

Device

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 outcomes

  1. 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).

  2. 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.

  3. Protein expression

    Time frame: baseline, immediately post-treatment (completion of rTMS)

    Peripheral blood will be collected to measure protein expression

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Gene expression

    Time frame: baseline, immediately post-treatment (completion of rTMS)

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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi-Ling Kuo, PT, PhD

CONTACT

[email protected]

3154646911

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 1, 2023
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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