Effectiveness of transcranial direct current stimulation and monoclonal antibodies acting on the CGRP as a combined treatment for migraine (TACTIC): Results of a randomized controlled trial
Abstract
Background Migraine pathogenesis involves both central and peripheral mechanisms. Although calcitonin gene-related peptide monoclonal antibodies have shown efficacy over placebo in migraine prevention, a proportion of individuals with migraine may experience a substantial residual burden while on treatment. Transcranial direct current stimulation is a non-invasive neuromodulation technique that can target central migraine mechanisms and may therefore complement calcitonin gene-related peptide monoclonal antibodies. The present study aimed to assess the efficacy of transcranial direct current stimulation as an adjunctive treatment to calcitonin gene-related peptide monoclonal antibodies in migraine prevention and to investigate its neurophysiological effects. Methods This is a multicenter, randomized double-blind, sham-controlled, parallel-group trial including subjects with migraine on treatment with calcitonin gene-related peptide monoclonal antibodies for ≥90 days and with ≥8 monthly migraine days in the last 30 days. Subjects were randomized to active or sham transcranial direct current stimulation. The transcranial direct current stimulation protocol consisted of five daily 20-minute sessions of bilateral cathodal stimulation on the occipital area and anodal stimulation on the M1 area. High-density electroencephalographic recordings were performed before the first and after the last transcranial direct current stimulation session. The primary endpoint was the number of…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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