Transcranial Alternating Current Stimulation Is Associated With Changes in EEG Microstate Dynamics in Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Resting-State EEG Microstate Parameters
研究概览
简要总结
Disorders of consciousness (DoC), including unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS), remain difficult to diagnose at the bedside. Electroencephalography (EEG) microstate analysis provides a high-temporal-resolution approach for characterizing large-scale resting-state brain dynamics, and its application in neuromodulation studies remains under investigation.
This study is designed to investigate the effects of a single 20-minute session of 40 Hz transcranial alternating current stimulation (tACS) applied over the bilateral dorsolateral prefrontal cortex (DLPFC) on resting-state EEG microstate parameters in patients with DoC. Participants undergo resting-state EEG recordings immediately before and after a 2 mA, 40 Hz bilateral DLPFC tACS session. EEG microstate maps (A-G) are identified by back-fitting to individual recordings, and microstate parameters including mean duration, occurrence, coverage, and global explained variance (GEV) are calculated. Behavioral assessments are performed using the Coma Recovery Scale-Revised (CRS-R) and the Simplified Evaluation of CONsciousness Disorders (SECONDs). The study aims to characterize changes in EEG microstate dynamics following tACS and to examine their associations with behavioral measures of consciousness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Medically stable at the time of assessment.
- •No administration of sedative or hypnotic medication within the previous 24 hours.
- •Preserved wakefulness (spontaneous or elicited by stimulation) with reduced or absent awareness, consistent with Unresponsive Wakefulness Syndrome (UWS) or Minimally Conscious State (MCS).
- •Diagnosis confirmed by an experienced neurologist using repeated clinical assessments with the Coma Recovery Scale-Revised (CRS-R) and the Simplified Evaluation of CONsciousness Disorders (SECONDs) performed on different days and at different times during periods of wakefulness.
排除标准
- •Acute phase of brain injury (within the first 28 days after injury).
- •Administration of sedative or hypnotic medication within the previous 24 hours.
- •Medical instability (e.g., active infection or hemodynamic instability).
- •Epileptic seizures uncontrolled despite anticonvulsant therapy.
- •Serious systemic illnesses that could affect the level of consciousness (e.g., sepsis or end-stage organ failure).
- •Brain death or coma without any evidence of wakefulness.
- •A previous history of developmental disorders, major neurological disorders, or severe psychiatric disorders associated with significant functional impairment.
研究组 & 干预措施
Disorders of Consciousness and TACS
We evaluated the effect of a single 20-minute session of 40 Hz transcranial alternating current stimulation (tACS) over the bilateral dorsolateral prefrontal cortex (DLPFC) on resting-state EEG microstate parameters in DoC and their relationships with behavioral consciousness scores.
干预措施: Transcranial Alternating Current Stimulation (Device)
结局指标
主要结局
Resting-State EEG Microstate Parameters
时间窗: Baseline and immediately after the 20-minute tACS session.
EEG recordings were obtained in different settings according to the patient's physical condition. From every individual, a total of 20 minutes of resting-state EEG was obtained. EEG recordings were performed using a Neurosoft NEURON-SPECTRUM-4 device and Neuron-Spectrum.NET software. Recordings were obtained from 19 electrode channels positioned according to the international 10-20 system: Fp1, Fp2, F7, F3, Fz, F4, F8, T7, C3, Cz, C4, T8, P7, P3, Pz, P4, P8, O1, O2. Data were digitized at a sampling rate of 500 Hz. Resting-state electroencephalography (EEG) microstate parameters, including mean duration, occurrence, coverage, and global explained variance (GEV) of microstate classes A-G, derived from 19-channel scalp EEG recordings using microstate analysis.
Coma Recovery Scale-Revised (CRS-R)
时间窗: Baseline and immediately after the 20-minute tACS session.
The CRS-R is a standardized clinical assessment tool used to evaluate the level of consciousness in patients with disorders of consciousness. It consists of six subscales: auditory, visual, motor, oromotor/verbal, communication, and arousal. The total score ranges from 0 to 23, with higher scores indicating a higher level of consciousness. Diagnostic interpretation is based not only on the total score but also on the highest behavioral responses observed within each subscale.
Simplified Evaluation of CONsciousness Disorders (SECONDs)
时间窗: Baseline and immediately after the 20-minute tACS session.
The SECONDs is a brief bedside assessment designed for the rapid evaluation of patients with disorders of consciousness. It assesses arousal and behavioral responses to simple commands and environmental stimuli. The total score ranges from 0 to 8, with higher scores indicating a better level of consciousness. It is a practical tool for screening and longitudinal clinical monitoring.
次要结局
未报告次要终点
研究者
eren toplutas
assistant professor
Istanbul Medipol University Hospital