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Principles and Practice of Clinical Research - Study Design



Adjuvant transcranial direct current stimulation in patients with chronic migraine: protocol of a randomized controlled trial

Tanya Morosoli, Silvia Amaro, Saule Balmagambetova, Renata A.F.S. Brandão, Livia de O Coutinho, Natália A.C. Duarte, Rodrigo S. Gaspar, Pascal Klaus, Alessandra K. Matsuno, Diego L. Pérez Monroy, Marco Pintucci, Lukas K.P. Prado, Anne C. Rumiato, Ana Daniela I. Sadovsky, Sascha Tafelski.

Abstract
Introduction: Chronic migraine (CM) is a common neurological disorder with a global prevalence range of about 2%. There is evidence that anodal motor transcranial direct current stimulation (tDCS) might be a promising adjuvant intervention in CM. This randomized controlled trial (RCT) aims to evaluate the efficacy of tDCS in reducing migraine episodes in CM patients on standard prophylactic medication.

Research hypothesis: tDCS, as an add-on to standard treatment, might reduce the frequency of CM episodes in adults when compared to standard treatment alone.

Methods: Adults with CM are included unless they meet the exclusion criteria (history of seizures; brain trauma or surgery; pregnancy; medication overuse; headache other than migraine; multiple or change of prophylactic medication in the last 3 months; metal prosthetics in the head or pacemaker).
This trial is designed as a triple blind, parallel-group, multicenter (three centers in U.S. north east geographical area), RCT, comparing an experimental group (tDCS + standard treatment) versus a control group (sham tDCS + standard treatment). According to a priori sample size calculation the inclusion of 100 subjects is estimated. The primary end point of the trial is the number of episodes during the 3 months study period.

Feasibility: This trial includes patients regularly treated in specialized centers. Number of patients, limited complexity of the intervention setting and time frame of study period are strengths of the protocol.

Anticipated results: In the experimental group, a significant reduction of number of migraine episodes, compared to the control group, is expected.

Key words: tDCS; transcranial direct current stimulation; migraine, chronic pain; RCT.


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