Department of Radiology and Biomedical Imaging, Yale University School of Medicine, New Haven, CT, United States of America.
Child Study Center, Yale University School of Medicine, New Haven, CT, United States of America.
Psychiatry Res Neuroimaging. 2023 Dec;336:111692. doi: 10.1016/j.pscychresns.2023.111692. Epub 2023 Jul 22.
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.
本文描述了一项针对抽动秽语综合征(TS)和慢性抽动障碍的神经反馈(NF)干预的随机对照临床试验方案。该干预措施涉及使用功能磁共振成像(fMRI)提供补充运动区活动的反馈:参与者在使用反馈作为训练信号的同时练习控制该脑区。该 NF 方案的先前版本已在一项针对青少年 TS 的小型研究(n=21)中进行了测试,结果具有临床前景。因此,我们计划进行更大规模的试验。在这里,我们描述了促使这项工作开展的背景文献、我们原始神经反馈研究方案的设计以及针对新试验对研究方案的调整。我们专注于那些可能引起其他 NF 研究设计者和执行者兴趣的方案理念。例如,我们强调了我们在对照组中确定要训练的无关脑区的方法,该方法基于识别与目标区域功能连通性较低的区域。为了透明和开放科学,我们在进行试验之前详细描述了新方案。