Micro-expressions in Patients With Prolonged Disorders of Consciousness (NCT06088628) | Clinical Trial Compass
RecruitingNot Applicable
Micro-expressions in Patients With Prolonged Disorders of Consciousness
China200 participantsStarted 2022-09-27
Plain-language summary
The goal of this observational study is to learn about the microexpressions in patients with prolonged disorders of consciousness. The main questions it aims to answer are:
* Inducing micro-expression changes in patients with prolonged disorders of consciousness through various emotional stimuli, and further to achieve precise classification of their levels of consciousness.
* Detecting micro-expressions in patients with prolonged disorders of consciousness to assist clinical diagnosis of levels of consciousness, e.g., complement the disgnosis of clinical scales such as CRS-r scale.
* By monitoring micro-expression changes in patients with prolonged disorders of consciousness, researchers can explore their residual brain function, thereby advancing research into relevant neural mechanisms.
Participants will be subjected to consciousness assessment by CRS-r scale, and their micro-expression changes in response to various emotional stimuli will be captured, along with the collection of EEG and MRI data. Follow-up evaluations will be conducted using the CRS-R scale and GOS scale, with a follow-up period of 6 months.
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 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;
. Aged between 18 and 80 years;
. Stable vital signs;
. Voluntary participation of family members with signed informed consent;
. Good cooperation, minimal facial and spontaneous activities, no use of antiepileptic or sedative drugs.
Exclusion criteria
. Locked-in syndrome;
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
GOSE score
Timeframe: six month
2
CRS-r score
Timeframe: six month
Trial details
NCT IDNCT06088628
SponsorFirst Affiliated Hospital of Zhejiang University