Combined Nonpharmacological Therapies for MTBI-Related Headaches
Veterans Medical Research Foundation
Summary
This study will assess the combined effectiveness of repetitive transcranial magnetic stimulation (rTMS) and telehealth based therapy in helping manage mild traumatic brain injury (mTBI) related headaches. The investigators hypothesize that active rTMS combined with telehealth therapy will provide marked reduction in mTBI related headaches and symptoms in comparison to their placebo counterparts.
Description
This study will be enrolling a total of 240 veterans or active military over a 4 year period at the VA San Diego Healthcare System (VASDHS). Participants will be randomized into one of four groups: Group A: active rTMS with telehealth headache management therapy Group B: active rTMS with telehealth headache education control Group C: sham rTMS with telehealth headache management therapy Group D: sham rTMS with telehealth headache education control Individual participation will consist of 19 visits to the VASDHS and 11 telehealth sessions over the course of 6-7 months. The in person visits wi…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Mild Traumatic Brain Injury (mTBI) 2. Chronic headaches \> 3 months after injury 3. Aged 18-65 4. No prior TMS treatment 5. Persistent Headaches with an intensity \> 30 / 100 6. No history of daily headache prior to mTBI Exclusion Criteria: 1. Pregnant 2. Pacemaker or any metal in body that would prevent MRI 3. History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia 4. Presence of any other chronic neuropathic pain states 5. History of seizure 6. Pending litigation 7. Can't understand English 8. History of chronic headache like migr…
Interventions
- DeviceActive rTMS
Active rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.
- BehavioralHeadache Management Therapy
Therapy will be provided on headache management.
- DeviceSham rTMS
Sham rTMS will be given at the left dorsolateral prefrontal cortex. All parameters of the treatment will appear identical to the active treatment, with only the rTMS coil used to administer the treatment flipped 180 degrees to prevent stimulation.
- BehavioralHeadache Education Control
In the control, educational sessions on headaches will be provided.
Location
- VA San Diego Healthcare SystemSan Diego, California