Psychology, University of Montreal, Montreal, Quebec, Canada.
Research Center, Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada.
BMJ Open. 2024 Jul 11;14(7):e078281. doi: 10.1136/bmjopen-2023-078281.
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.
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.
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).
NCT05833568.
意识障碍的治疗干预措施缺乏一致性；有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。本研究旨在验证多疗程经颅交流电刺激（tACS）干预亚急性脑损伤患者意识恢复、相关脑振荡和脑网络动力学的可行性，并评估其效果。
该研究包括两个阶段：验证阶段（n=12）和随机对照试验（n=138）。两个阶段都将在加拿大魁北克省蒙特利尔的 1 级创伤中心的重症监护病房中进行，接受连续镇静停药后格拉斯哥昏迷量表评分≤12 的脑损伤成年患者（创伤性脑损伤和缺氧缺血性脑病）。招募将在蒙特利尔 1 级创伤中心的重症监护病房进行，纳入标准为：格拉斯哥昏迷量表评分≤12 的脑损伤成年患者（创伤性脑损伤和缺氧缺血性脑病），连续镇静停药后。干预包括在顶枕部皮质部位进行 20 分钟 10 Hz tACS，强度为 1 mA，或假刺激，每天重复 5 次。电流的频率针对与意识相关的 alpha 脑振荡（8-13 Hz）。每天四次记录静息状态脑电图（EEG）五次连续日：干预前和干预后、刺激后 60 分钟和 120 分钟。还将包括两次额外的记录：刺激后 24 小时和 1 周。从基线到刺激后 1 周，将采集多模态测量（血液样本、瞳孔测量、行为意识评估（修订后的昏迷恢复量表）、活动测量）。EEG 信号分析将集中在 alpha 带宽（8-13 Hz）上，使用频谱和功能网络分析。刺激后 3、6 和 12 个月进行电话评估，测量长期功能恢复、生活质量和护理人员负担。
该研究已获得 CIUSSS du Nord-de-l'Île-de-Montréal 研究伦理委员会的批准（项目 ID 2021-2279）。这项两阶段研究的结果将提交给同行评议的学术期刊发表，并提交会议演讲。该试验的结果将在公共试验注册数据库（ClinicalTrials.gov）上公布。
NCT05833568。
