RecruitingPhase 1NCT06112093

Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

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


Sponsor

State University of New York - Upstate Medical University

Enrollment

60 participants

Start Date

Oct 23, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria8

  • 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 Criteria3

  • 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

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Interventions

DEVICERepetitive Transcranial Magnetic Stimulation

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

DEVICESham 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.


Locations(1)

SUNY Upstate Medical University

Syracuse, New York, United States

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NCT06112093


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