Combined Transcranial Magnetic Stimulation and Therapy for mTBI Related Headaches
Purpose
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.
Conditions
- TBI (Traumatic Brain Injury)
- Headache
- Depression
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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 migraine prior to mTBI 9. Evidence in chart of exacerbation of depressive/anxiety symptoms, active substance dependence, suicidal intent or attempt within previous month
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial Assignment
- Intervention Model Description
- Each participant will be randomized into one of 4 groups. Blocked randomization will be used with random block size of 4 or 8. Participants will be randomized to study groups in a 1:1:1:1 ratio.
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- The participant, study coordinators and the investigators will be blinded to the rTMS treatment. The participant will be blinded to the therapy group (headache management or headache education).
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Active rTMS with telehealth headache management therapy |
Participants receive both active rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management |
|
|
Other Active rTMS with telehealth headache education control |
Participants receive active rTMS treatment at the left dorsolateral prefrontal cortex and headache education |
|
|
Other Sham rTMS with telehealth headache management therapy |
Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management |
|
|
Sham Comparator Sham rTMS with telehealth headache education control |
Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and headache education |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Veterans Medical Research Foundation
Detailed 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 will be divided into the following phases: 1. PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments with MRI scan); 2. INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-12 (10 weekday neuronavigation guided rTMS sessions at >24 and <72 hours apart); and 3. POST-TREATMENT ASSESSMENTS AND MAINTENANCE TREATMENT PHASE (weeks 5-24) consists of 4 initial biweekly post-induction treatment assessments and maintenance treatments (Visits 13-16)) and two additional monthly post-induction assessments and maintenance treatments (Visits 17-18) and one final study visit (Visit 19). Eight weekly telehealth therapy/education sessions will be conducted from week 3 to 10 with additional three bolster sessions at 4 weeks apart. During the baseline and follow up visits, assessments will be conducted to evaluate headaches, neurobehavioral symptoms, depressive symptoms, post-concussion symptoms, and quality of life.
