Remotely Supervised At-home tDCS for Veterans with Persistent Post-Traumatic Headache: A Double-Blind, Sham-Controlled Randomized Pilot Clinical Trial

Abstract

Abstract Background. There is a scientific gap concerning the unmet need for treating persistent post-traumatic headache (PPTH) secondary to traumatic brain injury (TBI). No FDA approved therapy for PPTH is available. As such, the objective of the present trial was to evaluate the feasibility and preliminary efficacy of a four-week at-home remotely supervised transcranial direct current stimulation (RS-tDCS) intervention in veterans with PPTH secondary to mild TBI. Methods. Veterans with PPTH completed this single site, randomized, double-blind, sham-controlled pilot clinical trial. Following a baseline period (four-weeks), participants completed 20-sessions of RS-tDCS with real-time video monitoring. Participants were followed up for four-weeks post-intervention. Primary outcomes were overall treatment adherence rate (feasibility) and change in moderate/severe headache days (efficacy) during the treatment phase. Secondary outcomes were change in total number of headache days, Headache Impact Test, and other functional outcomes. Results. 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) RS-tDCS. Twenty-five veterans passed tolerability tests. Eighty-eight percent of participants fully completed either active (10/12) or sham (12/13) RS-tDCS interventions (p=.59). Moderate/severe headache days were significantly reduced within the active (difference=-2.5; 95% CI= [-4.98,-0.02]) but not sham group (difference=1.0; 95% CI= [-2.52,4.52]), however there was no statistically significant reduction when comparing active vs. shamgroups (B=-3.5; 95% CI= [-7.28,0.28]). There was a statistically significant reduction in total number of headache days within active RS-tDCS (difference=-4.0; 95% CI= [-7.71,-0.29]) but not sham (difference=0.58; 95% CI= [-2.52,3.69]). There was a statistically significant reduction in total number of headache days in active vs. sham RS-tDCS (B=-4.58; 95% CI= [-8.6,-0.56]). Conclusion. Our RS-tDCS paradigm enables safe, highly feasible, effective tDCS treatment. Clinical application of this RS-tDCS protocol will not only serve as an efficacious neuromodulation but also facilitate outreach to rural communities, where veterans have limited access to care related to PPTH. Trial Registry. ClinicalTrials.gov Identifier: NCT04012853