Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

Part of paid clinical trials in Syracuse, New York.

Sponsor
State University of New York - Upstate Medical University
Study ID
NCT06112093
Phase
PHASE1
Status
Recruiting
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Conditions

  • Brain Concussion
  • Headache
  • Mild Traumatic Brain Injury
  • Post-Concussion Symptoms

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Repetitive Transcranial Magnetic Stimulation — DEVICE
    rTMS will be used to regulate the motor cortex to reduce headaches and post-concussion symptoms.
  • 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.

Study Details

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.

Key Dates

Start date
Oct 23, 2023
Status verified
Oct 2025
Primary completion
Oct 23, 2026
Completion
Oct 23, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Moderate-dose rTMS
    12 sessions (1 session/day, 3 days/week for 4 weeks) of active rTMS
  • 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.
  • Active Comparator: High-dose rTMS
    24 sessions (4 sessions/day, 3 days/week for 2 weeks) of active rTMS
  • Active Comparator: Low-dose rTMS
    6 sessions (1 session/day, 3 days/week for 2 weeks) of active rTMS

Primary Outcome Measure

Daily headache diary [ Time Frame: daily documentation throughout the treatment course (4 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SUNY Upstate Medical UniversitySyracuseNew York13210
Yi-Ling Kuo, PT, PhD
[email protected]
3154646911

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By research site
SUNY Upstate Medical University· Syracuse, NY

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