Remotely Supervised tDCS for Persistent Post-Traumatic Headache in Veterans (ReStore)
Leigh Charvet1, Kiersten Mangold2, Adam Harrison3, Robert Davis Moore3, Siyuan Guo3, Jiajia Zhang3, Abhishek Datta4, Michelle Androulakis5
1NYU Langone, 2Arnold School of Public Health, 3University of South Carolina, 4Soterix Medical, 5Dorn VA Medical Center
Evaluate the feasibility and preliminary efficacy of a remotely supervised transcranial Direct Current Stimulation (RS-tDCS) intervention for persistent post-traumatic headache (PPTH) secondary to mild TBI (mTBI).
Veterans with PPTH completed a 28-day baseline observation of headache days and received either active or sham RS-tDCS paired with mindfulness meditation. This 4-week intervention of 20-minutes daily (M-F) at home RS-tDCS was monitored via VA Video Connect. Feasibility was determined by the number of participants completing at least 80% of the intervention. Preliminary efficacy was measured by changes in number of moderate/severe headache days from baseline period to the end of treatment phase, and to at a 4-week post-treatment  follow-up. Secondary endpoints included total number of headache days, acute pain medication use, as well as headache- and mTBI-related disability.
Twenty-six veterans (46.6±8.7 years) with PPTH completed baseline observations and were randomized to either active (n=13) or sham (n=13) treatment groups.  A total of 22/26 (85%) participants fully completed either active (10/13) or sham (12/13) interventions (p=.0.59). Within-group analyses reveled significant reductions in moderate/severe headache days in the active (p=0.04) but not sham (p=0.54) groups. This resulted in a trend towards significant reductions in moderate/severe headache days in the active vs. sham groups (p = 0.07). Active participants  also demonstrated a reduction in total number of headache days during treatment (p=0.04) where the sham group did not (p=0.70). This translated into a statistically significant reduction in total number of headache days during treatment for active vs. sham participants (p=0.03). No significant differences were maintained at the 4-week post-treatment follow-up (p’s>0.05).
RS-tDCS is feasible and effective for veterans with PPTH. Findings suggest that active RS-tDCS may reduce headache frequency and improve clinical outcomes.  A larger phase II study is warranted to confirm these findings and inform evaluation for clinical use.