2024年3月1日
The goal of this study is to describe a protocol for the home-based delivery of remotely supervised transcranial direct current stimulation (RS-tDCS) conserving the standard procedures of in-clinic practice, including safety, reproducibility, and tolerability. The participants included will be patients with phantom limb pain (PLP).
From all available treatments, recent studies using transcranial direct current stimulation, tDCS, have reported positive results when combining stimulation of the primary motor cortex, M1, with motor representation techniques. The long-term effects of the combined stimulation resulted in significant, maintained pain reduction after intervention and a follow-up period of three months. Our goal is to provide a visual guideline on how to perform a remote supervised tDCS session, as well as a description of the logistics and challenges of its implementation for treating phantom limb pain, especially in the context of a pragmatic clinical trial.
Another important contribution of this protocol is that most of the insights we are providing here can be translated to other studied population such as Parkinson's disease, traumatic brain injury, and post-stroke rehabilitation. Practical details and guidance on how to implement RS-tDCS for clinical trials on chronic pain are still limited in the literature, and they have the potential to accelerate the clinical application of the safe and effective intervention. And so on, facilitate its combination with the behavioral modalities that can be performed at home.
This trial will provide significant insights in how to use remotely supervised neuromodulation. After this trial, we'll focus on improving the delivery and methodology of home-based devices to increase the reach and the use of neuromodulation techniques in rehabilitation. We think that by addressing these questions, the clinical use of neuromodulation will increase.
本研究概述了一项针对幻肢痛(PLP)患者的家庭远程监督经颅直流电刺激(RS-tDCS)治疗的实施方案。该方案保留了门诊治疗中有关安全性和耐受性的实践规范,同时解决了远程应用相关的后勤挑战。
远程监督的家庭经颅直流电刺激(RS-tDCS)通过实现可扩展、以患者为中心的慢性疼痛研究干预递送方式,解决了神经调控研究中的一个关键障碍。该方案支持实用性试验的实施,并扩大了对机制性干预措施的可及性,有助于在传统临床环境之外开展可靠的数据收集。这一方法增强了针对神经系统疾病的大规模研发项目的转化连续性和操作可行性。
该RS-tDCS方案整合了从早期机制研究到实用临床验证的全过程,支持发现、筛选和转化研究阶段。