Study of Combined Transcranial Magnetic Stimulation and Telehealth Therapy for Managing Mild Traumatic Brain Injury Related Headaches in Adults 18 to 65

What this Trial Is About

Researchers are evaluating the combined use of repetitive transcranial magnetic stimulation rTMS and telehealth-based therapy to help manage headaches related to mild traumatic brain injury mTBI. The study involves veterans and active military personnel who experience persistent headaches after mTBI and aims to compare active rTMS with telehealth therapy against placebo treatments in reducing headache intensity and related symptoms. Participants will be randomly assigned to one of four groups combining active or sham rTMS with either telehealth headache management therapy or headache education control. The treatment includes 10 neuronavigation-guided rTMS sessions over two weeks, alongside weekly telehealth sessions for headache therapy or education from weeks 3 to 10, plus three additional monthly booster telehealth sessions. The study spans about 6 to 7 months with multiple phases including pre-treatment assessments, induction treatment, and post-treatment assessments with maintenance treatments. During the 19 in-person visits and 11 telehealth sessions, participants undergo MRI scans and assessments of headaches, neurobehavioral symptoms, depression, post-concussion symptoms, and quality of life. Researchers measure changes in headache intensity, frequency, and interference along with other symptom scales at multiple follow-up visits up to 20 weeks. This comprehensive evaluation helps monitor symptom changes and treatment effects throughout the study period.

Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches