Istituti Clinici Scientifici Maugeri IRCCS, Institute of Bari, Bari, Italy.
Department of Education, Psychology, Communication, University of Bari Aldo Moro, Bari, Italy.
PLoS One. 2024 May 31;19(5):e0304642. doi: 10.1371/journal.pone.0304642. eCollection 2024.
Disorders of consciousness (DOC), i.e., unresponsive wakefulness syndrome (UWS) or vegetative state (VS) and minimally conscious state (MCS), are conditions that can arise from severe brain injury, inducing widespread functional changes. Given the damaging implications resulting from these conditions, there is an increasing need for rehabilitation treatments aimed at enhancing the level of consciousness, the quality of life, and creating new recovery perspectives for the patients. Music may represent an additional rehabilitative tool in contexts where cognition and language are severely compromised, such as among DOC patients. A further type of rehabilitation strategies for DOC patients consists of Non-Invasive Brain Stimulation techniques (NIBS), including transcranial electrical stimulation (tES), affecting neural excitability and promoting brain plasticity.
We here propose a novel rehabilitation protocol for DOC patients that combines music-based intervention and NIBS in neurological patients. The main objectives are (i) to assess the residual neuroplastic processes in DOC patients exposed to music, (ii) to determine the putative neural modulation and the clinical outcome in DOC patients of non-pharmacological strategies, i.e., tES(control condition), and music stimulation, and (iii) to evaluate the putative positive impact of this intervention on caregiver's burden and psychological distress.
This is a randomised cross-over trial in which a total of 30 participants will be randomly allocated to one of three different combinations of conditions: (i) Music only, (ii) tES only (control condition), (iii) Music + tES. The music intervention will consist of listening to an individually tailored playlist including familiar and self-relevant music together with fixed songs; concerning NIBS, tES will be applied for 20 minutes every day, 5 times a week, for two weeks. After these stimulations two weeks of placebo treatments will follow, with sham stimulation combined with noise for other two weeks. The primary outcomes will be clinical, i.e., based on the differences in the scores obtained on the neuropsychological tests, such as Coma Recovery Scale-Revised, and neurophysiological measures as EEG, collected pre-intervention, post-intervention and post-placebo.
This study proposes a novel rehabilitation protocol for patients with DOC including a combined intervention of music and NIBS. Considering the need for rigorous longitudinal randomised controlled trials for people with severe brain injury disease, the results of this study will be highly informative for highlighting and implementing the putative beneficial role of music and NIBS in rehabilitation treatments.
ClinicalTrials.gov identifier: NCT05706831, registered on January 30, 2023.
意识障碍（DOC），即无反应性觉醒综合征（UWS）或植物状态（VS）和最小意识状态（MCS），是由严重脑损伤引起的病症，会导致广泛的功能变化。鉴于这些病症的破坏性影响，人们越来越需要康复治疗，以提高意识水平、生活质量，并为患者创造新的康复前景。音乐可能是认知和语言严重受损的 DOC 患者等情况下的另一种康复工具。DOC 患者的另一种康复策略是使用非侵入性脑刺激技术（NIBS），包括经颅电刺激（tES），以影响神经兴奋性并促进大脑可塑性。
我们在这里提出了一种针对 DOC 患者的新型康复方案，将基于音乐的干预措施与神经科患者的 NIBS 相结合。主要目标是：（i）评估接受音乐干预的 DOC 患者中残留的神经可塑性过程；（ii）确定非药物策略，即 tES（对照条件）和音乐刺激，对 DOC 患者的神经调节和临床结果的潜在影响；（iii）评估这种干预对照顾者负担和心理困扰的潜在积极影响。
这是一项随机交叉试验，共 30 名参与者将被随机分配到三种不同条件的组合之一：（i）仅音乐，（ii）仅 tES（对照条件），（iii）音乐 + tES。音乐干预将包括聆听个人定制的播放列表，其中包括熟悉和与自身相关的音乐以及固定歌曲；关于 NIBS，tES 将每天应用 20 分钟，每周 5 次，持续两周。在这些刺激之后，将进行两周的安慰剂治疗，同时进行假刺激和噪声治疗两周。主要结果将是临床的，即基于神经心理学测试（如修订后的昏迷恢复量表）和脑电图等神经生理测量结果的差异，这些测试在干预前、干预后和安慰剂后进行。
这项研究提出了一种针对 DOC 患者的新型康复方案，包括音乐和 NIBS 的联合干预。鉴于严重脑损伤疾病患者需要严格的纵向随机对照试验，本研究的结果将为强调和实施音乐和 NIBS 在康复治疗中的潜在有益作用提供重要信息。
ClinicalTrials.gov 标识符：NCT05706831，于 2023 年 1 月 30 日注册。
