Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches
- Conditions
- HeadacheBrain ConcussionPost-Concussion SymptomsMild Traumatic Brain Injury
- Interventions
- Device: Repetitive Transcranial Magnetic StimulationDevice: Sham Repetitive Transcranial Magnetic Stimulation
- Registration Number
- NCT06112093
- Lead Sponsor
- State University of New York - Upstate Medical University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 18 - 55 years old who were actively working prior to mTBI
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Repetitive transcranial magnetic stimulation (rTMS) Repetitive Transcranial Magnetic Stimulation 12 sessions (3 sessions/week) of active rTMS at the left motor cortex to upregulate brain excitability and reduce headaches and post-concussion symptoms. Sham rTMS Sham Repetitive Transcranial Magnetic Stimulation 12 sessions (3 sessions/week) of sham rTMS will be administered at the same location and duration as the active rTMS but will not modulate brain function. After the study is completed, participants will be offered an opportunity to receive active rTMS.
- Primary Outcome Measures
Name Time Method Daily headache diary 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).
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, 3) sleep disturbance, 4) sleep-related impairment 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.
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 - sleep quality baseline, immediately post-treatment (completion of rTMS) Kinematic assessments by the wrist actigraphy will be worn to measure sleep quality.
Wrist actigraphy - physical activity level baseline, immediately post-treatment (completion of rTMS) Kinematic assessments by the wrist actigraphy will be worn to measure physical activity level.
Neurophysiological measures by TMS baseline, immediately post-treatment (completion of rTMS) Neurophysiology will be measured by TMS to indicate changes in brain function.
Gene expression baseline, immediately post-treatment (completion of rTMS) Peripheral blood will be collected to measure mRNA to impute gene expression.
- Secondary Outcome Measures
Name Time Method Length of rehabilitation (LOR) immediately post-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up LOR will be recorded by reviewing the medical chart.
Return to work (RTW) immediately post-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up RTW will be will be calculated as the percent of time working relative to the pre-mTBI workload.
Trial Locations
- Locations (1)
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States