Micro-expressions in Patients With Prolonged Disorders of Consciousness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Facial expression; Electroencephalogram; MRI.
- Who it may be relevant to
- Registry conditions: Consciousness Disorders. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study of Micro-expressions in Patients With Prolonged Disorders of Consciousness
Overview
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.
Detailed description
In accordance with the inclusion and exclusion criteria, a total of about 200 participants will be recruited, including about 150 confirmed cases of prolonged disorders of consciousness and 50 healthy control subjects (HCs). Utilizing the random split algorithm from the machine learning library sklearn, the dataset will be randomly divided into a training set (70%) and a testing set (30%). General information about the participants such as age, gender, time and location of injury, as well as medical history, family history, medication history, and surgical history will be collected.
Participants will undergo dual-person, multiple assessments using the CRS-R scale to evaluate auditory, visual, motor, speech responsiveness, communication, and arousal levels. Micro-expression changes in response to various emotional stimuli will be collected, along with EEG and MRI data.
Follow-up evaluations will be conducted on all enrolled patients using the CRS-R scale and the GOS scale, with a follow-up period of 6 months.
Interventions
- Diagnostic test Facial expression; Electroencephalogram; MRI
Recording facial expressions of participants, EEG recordings, and MRI scans.
Primary outcome measures
- GOSE score [Time frame: six month]
- CRS-r score [Time frame: six month]
Eligibility criteria
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;
- Contraindications for EEG examination;
- Contraindications for MRI scanning, such as the presence of internal metallic implants;
- Diseases and factors that may affect brain function assessment, such as metabolic disorders, poisoning, shock, etc.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- First Affiliated Hospital,Zhejiang University — Hangzhou
Identifiers
NCT: NCT06088628 · Micro-expression