Remotely Supervised tDCS for Persistent Post-traumatic Headache: A Pilot Study

NIH RePORTER · VA · I21 · · view on reporter.nih.gov ↗

Abstract

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

Key facts

NIH application ID
9890706
Project number
1I21RX003194-01A1
Recipient
VETERANS HEALTH ADMINISTRATION
Principal Investigator
Xiao Michelle Androulakis
Activity code
I21
Funding institute
VA
Fiscal year
2020
Award amount
Award type
1
Project period
2019-10-01 → 2021-09-30