Department of Intensive Care Medicine and University Medical Center Utrecht Brain Center, University Medical Centre Utrecht, Utrecht, The Netherlands
Department of Psychiatry and University Medical Center Utrecht Brain Center, University Medical Centre Utrecht, Utrecht, The Netherlands.
BMJ Open. 2024 Nov 2;14(11):e092165. doi: 10.1136/bmjopen-2024-092165.
Delirium, a clinical manifestation of acute encephalopathy, is associated with extended hospitalisation, long-term cognitive dysfunction, increased mortality and high healthcare costs. Despite intensive research, there is still no targeted treatment. Delirium is characterised by electroencephalography (EEG) slowing, increased relative delta power and decreased functional connectivity. Recent studies suggest that transcranial alternating current stimulation (tACS) can entrain EEG activity, strengthen connectivity and improve cognitive functioning. Hence, tACS offers a potential treatment for augmenting EEG activity and reducing the duration of delirium. This study aims to evaluate the feasibility and assess the efficacy of tACS in reducing relative delta power.
A randomised, double-blind, sham-controlled trial will be conducted across three medical centres in the Netherlands. The study comprises two phases: a pilot phase (n=30) and a main study phase (n=129). Participants are patients aged 50 years and older who are diagnosed with delirium using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision criteria (DSM-5-TR), that persists despite treatment of underlying causes. During the pilot phase, participants will be randomised (1:1) to receive either standardised (10 Hz) tACS or sham tACS. In the main study phase, participants will be randomised to standardised tACS, sham tACS or personalised tACS, in which tACS settings are tailored to the participant. All participants will undergo daily 30 min of (sham) stimulation for up to 14 days or until delirium resolution or hospital discharge. Sixty-four-channel resting-state EEG will be recorded pre- and post the first tACS session, and following the final tACS session. Daily delirium assessments will be acquired using the Intensive Care Delirium Screening Checklist and Delirium Observation Screening Scale. The pilot phase will assess the percentage of completed tACS sessions and increased care requirements post-tACS. The primary outcome variable is change in relative delta EEG power. Secondary outcomes include (1) delirium duration and severity, (2) quantitative EEG measurements, (3) length of hospital stay, (4) cognitive functioning at 3 months post-tACS and (5) tACS treatment burden. Study recruitment started in April 2024 and is ongoing.
The study has been approved by the Medical Ethics Committee of the Utrecht University Medical Center and the Institutional Review Boards of all participating centres. Trial results will be disseminated via peer-reviewed publications and conference presentations.
NCT06285721.
谵妄是一种急性脑病的临床表现，与住院时间延长、长期认知功能障碍、死亡率增加和医疗保健费用增加有关。尽管进行了大量研究，但仍没有针对这种疾病的治疗方法。谵妄的特点是脑电图（EEG）减慢、相对δ波功率增加和功能连接减少。最近的研究表明，经颅交流电刺激（tACS）可以使 EEG 活动同步化，增强连接并改善认知功能。因此，tACS 为增强 EEG 活动和缩短谵妄持续时间提供了一种潜在的治疗方法。本研究旨在评估 tACS 减少相对 δ 波功率的可行性和疗效。
这项在荷兰三家医疗中心进行的随机、双盲、假对照试验包括两个阶段：一个是试点阶段（n=30），另一个是主要研究阶段（n=129）。参与者为年龄在 50 岁及以上的被诊断为谵妄的患者，这些患者符合《精神障碍诊断与统计手册》第五版修订版（DSM-5-TR）的标准，但尽管已经治疗了潜在病因，但仍持续存在谵妄。在试点阶段，参与者将被随机（1:1）分配接受标准（10 Hz）tACS 或假 tACS。在主要研究阶段，参与者将被随机分配接受标准 tACS、假 tACS 或个性化 tACS，其中 tACS 设置根据参与者进行调整。所有参与者将每天接受 30 分钟的（假）刺激，持续 14 天或直至谵妄缓解或出院。在第一次 tACS 治疗前和治疗后，将进行 64 通道静息状态 EEG 记录，以及最后一次 tACS 治疗后。将使用重症监护谵妄筛查检查表和谵妄观察筛查量表每天进行谵妄评估。试点阶段将评估完成 tACS 治疗的百分比和 tACS 治疗后增加的护理需求。主要观察变量是相对 δ EEG 功率的变化。次要观察指标包括（1）谵妄持续时间和严重程度，（2）定量 EEG 测量，（3）住院时间，（4）tACS 治疗后 3 个月的认知功能，以及（5）tACS 治疗负担。研究招募于 2024 年 4 月开始，目前正在进行中。
该研究已获得乌得勒支大学医学中心医学伦理委员会和所有参与中心机构审查委员会的批准。研究结果将通过同行评议的出版物和会议报告进行传播。
NCT06285721。
