Combining HD-tDCS with music stimulation for patients with prolonged disorders of consciousness: Study protocol for an RCT trial.

IF 1.7 4区医学 Q3 CLINICAL NEUROLOGY

NeuroRehabilitation Pub Date : 2024-01-01 DOI:10.3233/NRE-230282

Jie Yan, Fubing Zha, Juan Zhou, Jing Zhou, Jingpu Zhao, Qingfang Zhang, Jianjun Long, Dianrui Hou, Zhenhua Song, Yulong Wang

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引用次数: 0

Abstract

Background: Patients with prolonged disorders of consciousness (pDOC) pose significant challenges to healthcare workers due to their severe motor impairments and limited interaction with the environment. Non-invasive brain stimulation such as high-definition transcranial direct current stimulation (HD-tDCS) and music stimulation show promise in awakening this population.

Objective: In this study, we present a protocol aiming at investigating the efficacy of combined HD-tDCS and music stimulation in awakening patients with pDOC through a single-blind, randomized controlled trial.

Methods: Ninety patients with pDOC will be randomly divided into three groups: active HD-tDCS with music stimulation, active HD-tDCS, and sham HD-tDCS. All participants will receive 20 treatment sessions over a period of 10 days and the Coma Recovery Scale-Revised, Glasgow Outcome Scale and electroencephalogram will be used as assessment measures to evaluate their level of consciousness throughout the study. Adverse events and complications will be recorded during treatment. Within-group pre-post comparisons and between-group efficacy comparisons will be conducted to identify the most effective intervention approach. Statistical analysis will be performed using SPSS software with a significance level set at P < 0.05.

Conclusion: The pursuit of awakening therapy for patients with pDOC remains a clinical research challenge. This study protocol is designed with the aim of introducing an innovative non-pharmacological approach which combined HD-tDCS and music stimulation to facilitate the reinstatement of consciousness in patients with pDOC.

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将 HD-tDCS 与音乐刺激相结合治疗长时间意识障碍患者：一项 RCT 试验的研究方案。

背景：长期意识障碍（pDOC）患者因其严重的运动障碍和与环境的互动有限，给医护人员带来了巨大挑战。高清经颅直流电刺激（HD-tDCS）和音乐刺激等非侵入性脑刺激有望唤醒这类患者：在本研究中，我们提出了一项方案，旨在通过单盲随机对照试验，研究联合使用 HD-tDCS 和音乐刺激唤醒 pDOC 患者的疗效：90名pDOC患者将被随机分为三组：带音乐刺激的主动HD-tDCS组、主动HD-tDCS组和假HD-tDCS组。所有参与者将在 10 天内接受 20 次治疗，并在整个研究过程中使用昏迷恢复量表（修订版）、格拉斯哥结果量表和脑电图作为评估指标来评价患者的意识水平。治疗期间将记录不良事件和并发症。将进行组内前后比较和组间疗效比较，以确定最有效的干预方法。统计分析将使用 SPSS 软件进行，显著性水平设定为 P <0.05：对 pDOC 患者进行唤醒治疗仍是临床研究的一项挑战。本研究方案旨在引入一种创新的非药物疗法，结合高清多脉冲脑干刺激系统（HD-tDCS）和音乐刺激，以促进 pDOC 患者意识的恢复。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

NeuroRehabilitation CLINICAL NEUROLOGY-REHABILITATION

CiteScore

3.20

自引率

0.00%

发文量

178

审稿时长

6-12 weeks

期刊介绍： NeuroRehabilitation, an international, interdisciplinary, peer-reviewed journal, publishes manuscripts focused on scientifically based, practical information relevant to all aspects of neurologic rehabilitation. We publish unsolicited papers detailing original work/research that covers the full life span and range of neurological disabilities including stroke, spinal cord injury, traumatic brain injury, neuromuscular disease and other neurological disorders. We also publish thematically organized issues that focus on specific clinical disorders, types of therapy and age groups. Proposals for thematic issues and suggestions for issue editors are welcomed.