Clinical trial NCT06112093: Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches
Official title: Using Repetitive Transcranial Magnetic Stimulation to Manage Headaches and Improve Rehabilitation Outcomes in Mild Traumatic Brain Injury: A Longitudinal Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Brain Concussion
Mild Traumatic Brain Injury
Headache
Post-Concussion Symptoms
Keywords: Repetitive transcranial magnetic stimulation
Non-invasive brain stimulation
Neuromodulation
Chronic pain
Biomarkers
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Active rTMS group will receive 12 sessions (3 sessions/week) of rTMS and the Sham rTMS group will receive rTMS from a sham coil at the same location and duration as the Active rTMS group.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Daily headache diary
timeFrame: daily documentation throughout the treatment course (4 weeks)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Headache impact test 6 (HIT-6)
timeFrame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Post-Concussion Symptom Scale (PCSS)
timeFrame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Wrist actigraphy - sleep quality
timeFrame: baseline, immediately post-treatment (completion of rTMS)
measure: Wrist actigraphy - physical activity level
timeFrame: baseline, immediately post-treatment (completion of rTMS)
measure: Neurophysiological measures by TMS
timeFrame: baseline, immediately post-treatment (completion of rTMS)
measure: Gene expression
timeFrame: baseline, immediately post-treatment (completion of rTMS)
Secondary outcomes:
measure: Length of rehabilitation (LOR)
timeFrame: immediately post-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Return to work (RTW)
timeFrame: immediately post-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Yi-Ling Kuo, PT, PhD
role: PRINCIPAL_INVESTIGATOR
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