Objectives: To evaluate the feasibility and [efficacy] of transcranial Direct Current Stimulation (tDCS) administered at home [with real-time monitoring via VA Telehealth] remote supervision for persistent post traumatic headache (PTH) associated with mTBI, and the impact of this treatment on functional recovery in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) veterans. Methods: We will enroll [20] participants age 20-60 years old who meet the diagnostic criteria for persistent PTH associated with combat related mild TBI. tDCS will be remotely administrated for a total of 20 sessions over a four-week period. Primary endpoint: [To evaluate the changes in numbers of moderate to severe headache days per month from baseline period to the end of treatment phase, and to the end of follow-up phase]. Secondary endpoints: 1. To evaluate the changes of total number of headache days per month, acute pain mediation used based on number of doses of medication taken from baseline period to end of treatment phase, and to end of follow-up phase in the same cohort. 2. To evaluate the impact of headaches on the quality of life measures (pain and disability) based on change in Headache impact test-6 (HIT-6), Migraine disability assessment (MIDAS), Migraine Disability Assessment (MIDAS) scores, PHQ-9, PTSD severity as measured by PCL-5, and anxiety as measured by Backers anxiety inventory (BAI) from baseline period to end of treatment phase, and to end of follow-up phase in persistent PTH. Androulakis- 1
Better prevention and treatment options for persistent post traumatic headache in mild Traumatic Brain Injury (mTBI) is desperately needed for our Veterans. [This pilot study is designed to provide preliminary data for a large scale, randomized clinical trial to evaluate the efficacy of remotely administrated at home transcranial Direct Current Stimulation (tDCS) with real-time monitoring via VA Telehealth] for persistent post traumatic headache associated with mTBI. We anticipate that the results generated from the study will directly translate into immediate meaningful clinical application: not only in management of chronic post traumatic headache, but also in reduction of acute pain medication use, and improving quality of life for our veterans. Remote tDCS administration allows more frequent interventions, offers a unique advantage in terms of travel arrangement, healthcare utilization, recruitment for future clinical trials, and improved access for care. Androulakis- 1
