Randomized, sham-controlled trial of real-time fMRI neurofeedback for tics in adolescents with Tourette Syndrome

Abstract Background Activity in the supplementary motor area (SMA) has been associated with tics in Tourette Syndrome (TS). The aim of this study was to test a novel intervention – real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback from SMA – for reduction of tics in adolescents with TS. Methods Twenty-one adolescents with TS were enrolled in a double-blind, randomized, sham-controlled, crossover study involving two sessions of neurofeedback from their SMA. The primary outcome measure of tic severity was the Yale Global Tic Symptom Severity Scale (YGTSS) administered by an independent evaluator before and after each arm. The secondary outcome was control over the SMA assessed in neuroimaging scans where subjects were cued to increase/decrease activity in SMA without receiving feedback. Results All 21 subjects completed both arms of the study and all assessments. Participants had significantly greater reduction of tics on the YGTSS scale after neurofeedback as compared to sham (p + 4.6 at baseline to 19.9 + 5.7 at endpoint in neurofeedback and from 24.8 + 8.1 to 23.3 + 8.5 in sham. The 3.8-point difference is clinically meaningful and corresponds to an effect size of 0.59. However, there were no differences in changes on the secondary measure of control over the SMA. Conclusions This first randomized controlled trial of rt-fMRI neurofeedback in adolescents with TS suggests that this neurofeedback intervention may be helpful for improving tic symptoms. However, no effects were found in terms of change in control over the SMA, the hypothesized mechanism of action.