HD-tDCS Combined With Circadian Rhythm Reconstruction and Micro Expression Changes on Consciousne… (NCT05285124) | Clinical Trial Compass
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HD-tDCS Combined With Circadian Rhythm Reconstruction and Micro Expression Changes on Consciousness Recovery in Patients With Chronic Disturbance of Consciousness
China90 participantsStarted 2021-07-01
Plain-language summary
The circadian rhythm characteristics of sleep cycle and neuroendocrine in patients with chronic disorder of consciousness show different degrees of disorder, and the relationship between this disorder and consciousness level is unclear.The researchers used HD-tDCS to treat patients with chronic disturbance of consciousness who intervened in circadian rhythm, and used a variety of methods such as EEG, fMRI, protein metabolism, ERP and micro-expression to explore the mechanism of improving the state of consciousness of HD-DCS and the relationship between circadian rhythm and patients' consciousness level
Who can participate
Age range
18 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:
* Patients with diagnosis of disorder of consciousness
* Stable vital signs
* Good coordination, less spontaneous activity
* No anti-epileptic and sedative drugs taken within prior 24 hours
* The family members volunteered and signed the informed consent
Exclusion Criteria:
* locked-in syndrome
* Diseases and factors that may affect the judgment of brain function, such as metabolic diseases, poisoning, shock, etc.
* There are contraindications to MRI scanning, such as the presence of metal implants in the body
* Contraindications treated by transcranial direct current stimulation
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 Coma Recovery Scale-Revised (CRS-R) scale
Timeframe: Change from Baseline CRS-R at 14 days.
2
Electroencephalography (EEG)
Timeframe: Change from baseline EEG power spectral density at 14 days.
3
Sleep parameters
Timeframe: Change from baseline sleep patterns at 14 days.
4
Resting state fMRI
Timeframe: Change from ReHo, ALFF, fALFF and functional connectivity at 14 days.
5
Micro-expression
Timeframe: At baseline.
Trial details
NCT IDNCT05285124
SponsorFirst Affiliated Hospital of Zhejiang University