经颅直流电刺激对颅脑损伤后意识障碍患者的影响：一项随机、双盲对照试验的研究方案。
Effects of transcranial direct current stimulation on patients with disorders of consciousness after traumatic brain injury: study protocol for a randomized, double-blind controlled trial.
机构信息
Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, 330006, People's Republic of China.
First Clinical Medical School, Nanchang University, Nanchang, Jiangxi Province, 330006, People's Republic of China.
出版信息
Trials. 2019 Oct 17;20(1):596. doi: 10.1186/s13063-019-3680-1.
BACKGROUND
Disorders of consciousness (DOC) after traumatic brain injury (TBI) raise the mortality of patients, restrict the rehabilitation of patients with TBI, and increase the physical and economic burden that TBI imposes on patients and their families. Thus, treatment to promote early awakening in DOC after TBI is of vital importance. Various treatments have been reported, but there is no advanced evidence base to support them. Transcranial direct current stimulation (tDCS) has shown great potential in promoting neuroelectrochemical effects. This protocol is for a double-blind, randomized, controlled, clinical trial aiming to research the effects and safety of conventional rehabilitation combined with tDCS therapy in patients with DOC after TBI.
METHODS/DESIGN: Eighty patients with DOC after TBI will be randomized into one of two groups receiving conventional rehabilitation combined with sham tDCS or conventional rehabilitation combined with active tDCS. The intervention period in each of the two groups will last 4 weeks (20 min per day, 6 days per week). Primary outcomes (Glasgow Outcome Scale (GOS)) will be measured at baseline and the end of every week from the first to the fourth week. Secondary outcomes will be measured at baseline and the end of the fourth week. Adverse events and untoward effects will be measured during each treatment.
DISCUSSION
Patients with central nervous system lesions have received tDCS as a painless, non-invasive, easily applied and effective therapy for several decades, and there has been some evidence in recent years showing partial improvement on the level of consciousness of partial patients with DOC. However, reports mainly focus on the patients in a minimally conscious state (MCS), and there is a lack of large-sample clinical trials. This protocol presents an objective design for a randomized controlled trial that aims to study the effectiveness of conventional rehabilitation combined with tDCS therapy for DOC after TBI, to evaluate its safety, and to explore effective and economical therapeutic methods.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR1800014808 . Registered on 7 February 2018.
背景
颅脑创伤（TBI）后意识障碍（DOC）会增加患者的死亡率，限制 TBI 患者的康复，并增加 TBI 给患者及其家庭带来的身体和经济负担。因此，促进 TBI 后 DOC 早期觉醒的治疗至关重要。已经报道了各种治疗方法，但没有高级别的证据支持它们。经颅直流电刺激（tDCS）在促进神经电化学效应方面显示出巨大的潜力。本方案是一项双盲、随机、对照、临床试验，旨在研究常规康复联合 tDCS 治疗 TBI 后 DOC 患者的疗效和安全性。
方法/设计：将 80 例 TBI 后 DOC 患者随机分为两组，分别接受常规康复联合假 tDCS 或常规康复联合真 tDCS 治疗。两组的干预期均为 4 周（每天 20 分钟，每周 6 天）。主要结局（Glasgow 结局量表（GOS））将在基线和第 1 至第 4 周每周结束时进行测量。次要结局将在基线和第 4 周结束时进行测量。在每次治疗期间测量不良事件和不良反应。
讨论
几十年来，接受中枢神经系统病变的患者接受 tDCS 治疗作为一种无痛、非侵入性、易于应用且有效的治疗方法，近年来有一些证据表明，部分 DOC 患者的意识水平有所改善。然而，报告主要集中在最小意识状态（MCS）的患者，缺乏大样本临床试验。本方案提出了一项随机对照试验的客观设计，旨在研究常规康复联合 tDCS 治疗 TBI 后 DOC 的有效性，评估其安全性，并探索有效和经济的治疗方法。
试验注册
中国临床试验注册中心，ChiCTR1800014808。注册于 2018 年 2 月 7 日。
Zotero 插件