Non-Invasive Neuromodulation for Episodic and Chronic Migraine Headache: Preliminary Findings on Feasibility of At-Home Transcranial Direct Current Stimulation With Remote Supervision

Abstract

Background: The outcomes of drug therapies in migraine vary and the development of novel non-pharmacological treatments is a priority. Non-invasive neuromodulation using transcranial direct current stimulation (tDCS) in small-sample studies with brief treatment protocols has shown preliminary efficacy in management of migraine symptoms. We have piloted a use of tDCS modified for applications of longer treatment protocols in home settings and conducted a pilot randomized sham-controlled study involving 60 daily at-home tDCS applications in migraine patients (targeted N = 60). The COVID-19 pandemic precipitated early study closure, and the final enrollment (N = 22) was insufficient to test efficacy. Here we report findings on treatment feasibility, adherence, and satisfaction. Methods: Participants were enrolled from the New York metropolitan area in 2018 - 2020. Main eligibility criteria included diagnosis of episodic or chronic migraine, history of headache for ≥ 1 year and ≥ 4 days with headache per month during a 30-day baseline period. At-home tDCS with remote supervision delivered the current at intensity of 1.5 mA or sham for one 20-min session per day on 60 consecutive days. The feasibility was determined by the drop-out rate after treatment started. Adherence was measured as the proportion of days during the 60-day study period that the patient activated the device. Satisfaction was evaluated from the satisfaction survey completed after the 60-day use of the device. Results: Thirty-six patients provided consent and were assessed for eligibility; 22 of them (17 F, 5 M, age of 38.4 ± 11.0 years) met eligibility criteria and were enrolled. Six patients dropped out after the intervention started; 16 patients (73% of enrolled) continued through the 60-day treatment. In this group, adherence was high; the mean (standard deviation (SD)) number of sessions per patient was 49.3 (13.1); the median was 52.5. All 16 patients were satisfied with education about tDCS and 13 (81%) found the use of the tDCS device easy. No significant adverse events occurred. Conclusions: At-home tDCS with remote supervision is feasible in migraine patients. If efficacy is confirmed in future research, at-home tDCS could become a useful tool for patients with severe migraine headache.