Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches

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:

• PRE-TREATMENT ASSESSMENTS PHASE (weeks 1-2) which consists of Visit 1 (Screening Visit) and Visit 2 (Baseline Assessments with MRI scan);
• INDUCTION TREATMENT PHASE (weeks 3-4) consists of Visits 3-12 (10 weekday neuronavigation guided rTMS sessions at >24 and <72 hours apart); and
• 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.

Inclusion criteria

• Mild Traumatic Brain Injury (mTBI)
• Chronic headaches > 3 months after injury
• Aged 18-65
• No prior TMS treatment
• Persistent Headaches with an intensity > 30 / 100
• No history of daily headache prior to mTBI

Exclusion criteria

• Pregnant
• Pacemaker or any metal in body that would prevent MRI
• History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia
• Presence of any other chronic neuropathic pain states
• History of seizure
• Pending litigation
• Can't understand English
• History of chronic headache like migraine prior to mTBI
• Evidence in chart of exacerbation of depressive/anxiety symptoms, active substance dependence, suicidal intent or attempt within previous month