Jie Yan, Fubing Zha, Juan Zhou, Jing Zhou, Jingpu Zhao, Qingfang Zhang, Jianjun Long, Dianrui Hou, Zhenhua Song, Yulong Wang
{"title":"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。","authors":"Jie Yan, Fubing Zha, Juan Zhou, Jing Zhou, Jingpu Zhao, Qingfang Zhang, Jianjun Long, Dianrui Hou, Zhenhua Song, Yulong Wang","doi":"10.3233/NRE-230282","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":19717,"journal":{"name":"NeuroRehabilitation","volume":" ","pages":"495-504"},"PeriodicalIF":1.7000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11091638/pdf/","citationCount":"0","resultStr":"{\"title\":\"Combining HD-tDCS with music stimulation for patients with prolonged disorders of consciousness: Study protocol for an RCT trial.\",\"authors\":\"Jie Yan, Fubing Zha, Juan Zhou, Jing Zhou, Jingpu Zhao, Qingfang Zhang, Jianjun Long, Dianrui Hou, Zhenhua Song, Yulong Wang\",\"doi\":\"10.3233/NRE-230282\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Conclusion: </strong>The pursuit of awakening therapy for patients with pDOC remains a clinical research challenge. 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Combining HD-tDCS with music stimulation for patients with prolonged disorders of consciousness: Study protocol for an RCT trial.
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.
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.
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