Transcranial Alternating Current Stimulation in Patients With Disorders of Consciousness (NCT06211439) | Clinical Trial Compass
UnknownNot Applicable
Transcranial Alternating Current Stimulation in Patients With Disorders of Consciousness
China64 participantsStarted 2022-12-05
Plain-language summary
In recent years, many literatures have reported that tACS, as a non-invasive electrical brain stimulation technique, has been applied in depression, schizophrenia, dementia and other fields.
The goal of this study is to explore the clinical efficacy and mechanism of action of HD-tACS in patients with chronic disorders of consciousness.The main questions it aims to answer are:
1. Explore the neurophysiological effects of HD-tACS on patients with chronic disorders of consciousness under theta and gamma frequency stimulation, and observe its impact on behavioral changes and long-term prognosis;
2. Further investigate the awakening mechanism of consciousness disorders through HD-tACS stimulation using multimodal assessment;
3. Clarify the role of theta and gamma neural oscillations in consciousness disorders, providing new targets for the pathogenesis and treatment of Disorders of Consciousness .
Who can participate
Age range
14 Years – 80 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:
* 1\. Patients with consciousness disorders for more than 28 days following severe brain injury, assessed by the CRS-R scale to meet the criteria for VS or MCS; 2. Aged between 14 and 80 years; 3. Stable vital signs; 4. No neuromuscular function blockers and no sedation within the prior 24 hours;
Exclusion Criteria:
* 1\. Locked-in syndrome; 2. Contraindications for EEG examination;HD-tACS stimulation. 3. Contraindications for MRI scanning, such as the presence of internal metallic implants; 4. Diseases and factors that may affect brain function assessment, such as metabolic disorders, poisoning, shock, etc.
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
the JFK Coma Recovery Scale-Revised (CRS-R) scale
Timeframe: at baseline (T0), immediately after the end of the treatment (T1), 5 days later (T2).Investigators observed the changes from baseline to the end of stimulation
Trial details
NCT IDNCT06211439
SponsorFirst Affiliated Hospital of Zhejiang University