Brain Concussion, Headache, Mild Traumatic Brain Injury, Post-Concussion Symptoms
Conditions
Keywords
Repetitive transcranial magnetic stimulation, Non-invasive brain stimulation, Neuromodulation, Chronic pain, Biomarkers
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.
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.
Sponsors
State University of New York - Upstate Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gene expression | baseline, immediately post-treatment (completion of rTMS) | Peripheral blood will be collected to measure mRNA to impute gene expression. |
| 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 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. |
| Protein expression | baseline, immediately post-treatment (completion of rTMS) | Peripheral blood will be collected to measure protein expression |
| Neurophysiological measures by TMS | baseline, immediately post-treatment (completion of rTMS) | Neurophysiology will be measured by TMS to indicate changes in brain function. |
| 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 - physical activity level | baseline, immediately post-treatment (completion of rTMS) | Kinematic assessments by the wrist actigraphy will be worn to measure physical activity level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wrist actigraphy - sleep quality | baseline, immediately post-treatment (completion of rTMS) | Kinematic assessments by the wrist actigraphy will be worn to measure sleep quality. |
Countries
United States
Contacts
Primary ContactYi-Ling Kuo, PT, PhD
Outcome results
None listed