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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Resting-State EEG Microstate Parameters
Timeframe: Baseline and immediately after the 20-minute tACS session.
2
Coma Recovery Scale-Revised (CRS-R)
Timeframe: Baseline and immediately after the 20-minute tACS session.
3
Simplified Evaluation of CONsciousness Disorders (SECONDs)
Timeframe: Baseline and immediately after the 20-minute tACS session.