PDF(Pubmed)
Abstract：
BACKGROUND: Therapeutic interventions for disorders of consciousness lack consistency; evidence supports non-invasive brain stimulation, but few studies assess neuromodulation in acute-to-subacute brain-injured patients. This study aims to validate the feasibility and assess the effect of a multi-session transcranial alternating current stimulation (tACS) intervention in subacute brain-injured patients on recovery of consciousness, related brain oscillations and brain network dynamics.
METHODS: The study is comprised of two phases: a validation phase (n=12) and a randomised controlled trial (n=138). Both phases will be conducted in medically stable brain-injured adult patients (traumatic brain injury and hypoxic-ischaemic encephalopathy), with a Glasgow Coma Scale score ≤12 after continuous sedation withdrawal. Recruitment will occur at the intensive care unit of a Level 1 Trauma Centre in Montreal, Quebec, Canada. The intervention includes a 20 min 10 Hz tACS at 1 mA intensity or a sham session over parieto-occipital cortical sites, repeated over five consecutive days. The current\'s frequency targets alpha brain oscillations (8-13 Hz), known to be associated with consciousness. Resting-state electroencephalogram (EEG) will be recorded four times daily for five consecutive days: pre and post-intervention, at 60 and 120 min post-tACS. Two additional recordings will be included: 24 hours and 1-week post-protocol. Multimodal measures (blood samples, pupillometry, behavioural consciousness assessments (Coma Recovery Scale-revised), actigraphy measures) will be acquired from baseline up to 1 week after the stimulation. EEG signal analysis will focus on the alpha bandwidth (8-13 Hz) using spectral and functional network analyses. Phone assessments at 3, 6 and 12 months post-tACS, will measure long-term functional recovery, quality of life and caregivers\' burden.
BACKGROUND: Ethical approval for this study has been granted by the Research Ethics Board of the CIUSSS du Nord-de-l\'Île-de-Montréal (Project ID 2021-2279). The findings of this two-phase study will be submitted for publication in a peer-reviewed academic journal and submitted for presentation at conferences. The trial\'s results will be published on a public trial registry database (ClinicalTrials.gov).
BACKGROUND: NCT05833568.
METHODS: The study is comprised of two phases: a validation phase (n=12) and a randomised controlled trial (n=138). Both phases will be conducted in medically stable brain-injured adult patients (traumatic brain injury and hypoxic-ischaemic encephalopathy), with a Glasgow Coma Scale score ≤12 after continuous sedation withdrawal. Recruitment will occur at the intensive care unit of a Level 1 Trauma Centre in Montreal, Quebec, Canada. The intervention includes a 20 min 10 Hz tACS at 1 mA intensity or a sham session over parieto-occipital cortical sites, repeated over five consecutive days. The current\'s frequency targets alpha brain oscillations (8-13 Hz), known to be associated with consciousness. Resting-state electroencephalogram (EEG) will be recorded four times daily for five consecutive days: pre and post-intervention, at 60 and 120 min post-tACS. Two additional recordings will be included: 24 hours and 1-week post-protocol. Multimodal measures (blood samples, pupillometry, behavioural consciousness assessments (Coma Recovery Scale-revised), actigraphy measures) will be acquired from baseline up to 1 week after the stimulation. EEG signal analysis will focus on the alpha bandwidth (8-13 Hz) using spectral and functional network analyses. Phone assessments at 3, 6 and 12 months post-tACS, will measure long-term functional recovery, quality of life and caregivers\' burden.
BACKGROUND: Ethical approval for this study has been granted by the Research Ethics Board of the CIUSSS du Nord-de-l\'Île-de-Montréal (Project ID 2021-2279). The findings of this two-phase study will be submitted for publication in a peer-reviewed academic journal and submitted for presentation at conferences. The trial\'s results will be published on a public trial registry database (ClinicalTrials.gov).
BACKGROUND: NCT05833568.
摘要：
背景：意识障碍的治疗干预措施缺乏一致性；证据支持非侵入性脑刺激，但很少有研究评估急性至亚急性脑损伤患者的神经调节。本研究旨在验证多节次经颅交流电流刺激（tACS）干预对亚急性脑损伤患者意识恢复的可行性和效果。相关的大脑振荡和大脑网络动力学。
方法：该研究包括两个阶段：验证阶段（n=12）和随机对照试验（n=138）。这两个阶段将在医学上稳定的脑损伤成年患者（创伤性脑损伤和缺氧缺血性脑病）中进行，持续镇静停药后，格拉斯哥昏迷评分≤12分。招募将在蒙特利尔一级创伤中心的重症监护室进行，魁北克,加拿大。干预包括在1mA强度下进行20分钟10HztACS或在顶枕骨皮质部位进行假手术，连续五天重复。当前频率的目标是阿尔法脑振荡(8-13赫兹)，已知与意识有关。静息状态脑电图（EEG）将连续五天每天记录四次：干预前和干预后，在tACS后60和120分钟。将包括另外两个记录：协议后24小时和1周。多模式措施(血液样本，瞳孔测量,行为意识评估(昏迷恢复量表修订)，活动记录测量）将从基线获得，直到刺激后1周。EEG信号分析将使用频谱和功能网络分析集中在alpha带宽（8-13Hz）上。tACS后3、6和12个月的电话评估，将衡量长期功能恢复，生活质量和照顾者的负担。
背景：本研究的伦理批准已由CIUSSSduNord-de-l的研究伦理委员会批准（项目ID2021-2279）。这项两阶段研究的结果将提交在同行评审的学术期刊上发表，并提交在会议上发表。试验结果将公布在公共试验注册数据库（ClinicalTrials.gov）上。
背景：NCT05833568。
方法：该研究包括两个阶段：验证阶段（n=12）和随机对照试验（n=138）。这两个阶段将在医学上稳定的脑损伤成年患者（创伤性脑损伤和缺氧缺血性脑病）中进行，持续镇静停药后，格拉斯哥昏迷评分≤12分。招募将在蒙特利尔一级创伤中心的重症监护室进行，魁北克,加拿大。干预包括在1mA强度下进行20分钟10HztACS或在顶枕骨皮质部位进行假手术，连续五天重复。当前频率的目标是阿尔法脑振荡(8-13赫兹)，已知与意识有关。静息状态脑电图（EEG）将连续五天每天记录四次：干预前和干预后，在tACS后60和120分钟。将包括另外两个记录：协议后24小时和1周。多模式措施(血液样本，瞳孔测量,行为意识评估(昏迷恢复量表修订)，活动记录测量）将从基线获得，直到刺激后1周。EEG信号分析将使用频谱和功能网络分析集中在alpha带宽（8-13Hz）上。tACS后3、6和12个月的电话评估，将衡量长期功能恢复，生活质量和照顾者的负担。
背景：本研究的伦理批准已由CIUSSSduNord-de-l的研究伦理委员会批准（项目ID2021-2279）。这项两阶段研究的结果将提交在同行评审的学术期刊上发表，并提交在会议上发表。试验结果将公布在公共试验注册数据库（ClinicalTrials.gov）上。
背景：NCT05833568。
