Home-based transcranial direct current stimulation (tDCS) and motor imagery for phantom limb pain using statistical learning to predict treatment response: an open-label study protocol.
Home-based transcranial direct current stimulation (tDCS) and motor imagery for phantom limb pain using statistical learning to predict treatment response: an open-label study protocol.
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DOI：
10.21801/ppcrj.2021.74.2
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发表时间：
2021
期刊：
影响因子：
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通讯作者：
Fregni F
中科院分区：
文献类型：
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作者：
Pacheco-Barrios K;Cardenas-Rojas A;de Melo PS;Marduy A;Gonzalez-Mego P;Castelo-Branco L;Mendes AJ;Vásquez-Ávila K;Teixeira PEP;Gianlorenco ACL;Fregni F
由于反应异质性和缺乏治疗途径，幻肢痛 (PLP) 的治疗一直是一个挑战。本研究将评估远程家庭 M1 阳极 tDCS 结合运动想象对幻肢患者的可行性，并评估该疗法的初步疗效、安全性和反应预测因素。这是一项试点、单臂、开放标签试验，我们将招募 10 名患有幻肢痛的受试者。该研究将包括 20 个课程。所有参与者都将接受主动阳极 M1 tDCS 结合幻肢运动想象训练。我们的主要结果将是这种联合干预措施的可接受性和可行性。此外，我们将评估治疗后的初步临床（疼痛强度）和生理（运动抑制任务和心率变异性）变化。最后，我们将实施监督统计学习 (SL) 模型来识别 PLP 患者治疗反应（对 tDCS 和幻肢运动想象）的预测因素。我们还将使用之前临床试验的数据（总观察值 = 224 [n = 112 x 时间点 = 2））用于我们的统计学习算法。这项开放标签研究的新前瞻性数据将用作独立的测试数据集。该协议提议评估一种新型神经调节联合干预措施的可行性，该干预措施将允许设计更大规模的远程临床试验，从而增加 PLP 患者获得安全有效治疗的机会。此外，这项研究将使我们能够确定疼痛反应和 PLP 临床内型的可能预测因子。
Phantom limb pain (PLP) management has been a challenge due to its response heterogeneity and lack of treatment access. This study will evaluate the feasibility of a remotely home-based M1 anodal tDCS combined with motor imagery in phantom limb patients and assess the preliminary efficacy, safety, and predictors of response of this therapy. This is a pilot, single-arm, open-label trial in which we will recruit 10 subjects with phantom limb pain. The study will include 20 sessions. All participants will receive active anodal M1 tDCS combined with phantom limb motor imagery training. Our primary outcome will be the acceptability and feasibility of this combined intervention. Moreover, we will assess preliminary clinical (pain intensity) and physiological (motor inhibition tasks and heart rate variability) changes after treatment. Finally, we will implement a supervised statistical learning (SL) model to identify predictors of treatment response (to tDCS and phantom limb motor imagery) in PLP patients. We will also use data from our previous clinical trial (total observations=224 [n=112 x timepoints = 2)) for our statistical learning algorithms. The new prospective data from this open-label study will be used as an independent test dataset. This protocol proposes to assess the feasibility of a novel, neuromodulatory combined intervention that will allow the design of larger remote clinical trials, thus increasing access to safe and effective treatments for PLP patients. Moreover, this study will allow us to identify possible predictors of pain response and PLP clinical endotypes.