Transcranial DC Stimulation in Patients with Migraine: a study protocol for a randomized clinical trial

Background Chronic migraine is a disease with a difficult diagnosis and an as yet undefined pathophysiology. Its symptoms affect the quality of life and the daily activities of the individual, leading to momentary disability. This study is a controlled clinical trial of a randomized parallel group that will select patients aged between 18–65 years who are diagnosed with chronic migraine. Methods / Design This study will be held at the Aging Studies Laboratory and Neuroscience of the Federal University of Paraíba, where twelve sessions of transcranial direct current stimulation (tDCS) and associated with mindfulness practices will be applied over four weeks (one per week). Muse, a portable electroencephalogram (EEG), will be used to measure brain wave biomarkers before and after the intervention. We will use, at the beginning and end of treatment and one month after the completion of any intervention, the score on the Migraine Disability Assessment (MIDAS) questionnaire as the primary outcome and the scores on the HIT-6 (Headache Impact Test) questionnaire and on the Five Facet Mindfulness Questionnaire (FFMQ-BR) as the secondary outcomes. Discussion Based on the use of tDCS in patients with chronic pain, and in benefits of Mindfulness practice in these patients, the objective is to evaluate if the mindfulness-associated tD provides satisfactory results in the painful prophylaxis of patients with chronic migraine. Trial registration Clinicaltrials.gov, NCT04219345. Registered 16 September 2019. Retrospectively registered.