Protocol description for a randomized controlled trial of fMRI neurofeedback for tics in adolescents with Tourette Syndrome.

This article describes the protocol for a randomized, controlled clinical trial of a neurofeedback (NF) intervention for Tourette Syndrome (TS) and chronic tic disorder. The intervention involves using functional magnetic resonance imaging (fMRI) to provide feedback regarding activity in the supplementary motor area: participants practice controlling this brain area while using the feedback as a training signal. The previous version of this NF protocol was tested in a small study (n = 21) training adolescents with TS that yielded clinically promising results. Therefore, we plan a larger trial. Here we describe the background literature that motivated this work, the design of our original neurofeedback study protocol, and adaptations of the research study protocol for the new trial. We focus on those ideas incorporated into our protocol that may be of interest to others designing and running NF studies. For example, we highlight our approach for defining an unrelated brain region to be trained in the control group that is based on identifying a region with low functional connectivity to the target area. Consistent with a desire for transparency and open science, the new protocol is described in detail here prior to conducting the trial.

Neurofeedback for obsessive compulsive disorder: A randomized, double-blind trial.

We aim to develop fMRI neurofeedback as a treatment for obsessive compulsive disorder (OCD). In prior work, we found that providing neurofeedback of activity in the anterior prefrontal cortex (aPFC) improved control over contamination anxiety in a subclinical population. Here, we present the results of a randomized, double-blind clinical trial (NCT02206945) testing this intervention in patients with OCD. We recruited patients with primary symptoms in the fear-of-harm/checking or contamination/washing domains. During neurofeedback, they viewed symptom provocative images and attempted to up- and down-regulate the aPFC during different blocks of time. The active group received two sessions of neurofeedback and the control group received yoked sham feedback. The primary outcome measure was the Yale-Brown Obsessive-Compulsive Symptom scale. The secondary outcome was control over aPFC. Thirty-six participants completed feedback training (18 active, 18 control). The active group had a slightly but significantly greater reduction of obsessive-compulsive symptoms after neurofeedback compared to the control group (p<.05) but no significant differences in control over the aPFC. These data demonstrate that neurofeedback targeting the aPFC can reduce symptoms in OCD. Future investigations should seek to optimize the training protocol to yield larger effects and to clarify the mechanism of action.

Feasibility of online behavioral clinical trials: The future of weight management randomized clinical trials?

Objective: Behavioral weight management trials are traditionally conducted in-person. The COVID-19 shutdown halted in-person operations, forcing investigators to develop new methods for remote treatment and assessment delivery without additional funding for website development or remote equipment. This study examined the feasibility and acceptability of remote procedures from an ongoing weight management trial impacted by COVID-19. Methods: Using a quasi-experimental longitudinal design, in-person (pre-COVID) and remote (COVID) treatment and assessment procedures were used. Attendance at in-person versus remote (videoconference) treatment sessions was compared. Acceptability of treatment modalities (in-person vs. remote) was examined via self-report. Validity and reliability were assessed on bathroom scales. Attendance at remote (videoconference + mailed, scales) versus in-person assessment sessions was compared. Finally, exploratory analyses were conducted to determine whether participant characteristics moderated the effects. Results: Remote treatment attendance was significantly better than in-person. Overall, there was no significant difference in modality preference. However, Hispanic (vs. non-Hispanic) individuals had greater preference for remote options and attended more remote treatment sessions. Bathroom scales demonstrated excellent validity and reliability. Adherence to remote and in-person assessment sessions was similar. Conclusions: COVID-19 has provided an opportunity to rethink how we conduct research. Results herein establish an evidence-base to support a paradigm shift to remote clinical trial procedures. Such a shift may enhance diversity in clinical trials.