Chronic migraine is a difficult disease to diagnose, and its pathophysiology remains undefined. Its symptoms affect the quality of life and daily living tasks of the affected person, leading to momentary disability. This is a pilot, randomized, controlled, double-blind clinical trial study with female patients between 18 and 65 years old with chronic migraine. The patients underwent twelve mindfulness sessions paired with anodal transcranial direct-current stimulation (tDCS) over the left dorsolateral prefrontal cortex (DLPFC), with current intensity of 2 mA applied for 20 min, three times a week for 4 weeks. In addition, 20 min of mindfulness home practices were performed by guided meditation audio files. A total of 30 participants were evaluated after the treatment, and these were subdivided into two groups—active tDCS and sham tDCS, both set to mindfulness practice. The FFMQ-BR (Five Facet of Mindfulness Questionnaire), MIDAS (Migraine Disability Assessment), and HIT-6 (Headache Impact Test) questionnaires were used to evaluate the outcomes. After the treatment, the active mindfulness and tDCS group showed better results in all outcomes. The sham group also showed improvements, but with smaller effect sizes compared to the active group. The only significant difference in the intergroup analysis was the outcome evaluated by HIT-6 in the post treatment result. Our results provide the first therapeutic evidence of mindfulness practices associated with left DLPFC anodal tDCS with a consequent increase in the level of full attention and analgesic benefits in the clinical symptoms of patients with chronic migraine.
BackgroundChronic 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 / DesignThis 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.DiscussionBased 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 registrationClinicaltrials.gov, NCT04219345. Registered 16 September 2019. Retrospectively registered.
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