Micro-expressions in Patients With Prolonged Disorders of Consciousness

Recruiting

• Conditions: Consciousness Disorders
• Interventions: Diagnostic Test: Facial expression; Electroencephalogram; MRI

• Registration Number: NCT06088628
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief 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.

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.

Study Timeline

• Study Start: 2022-06-27
• Status Verified: 2023-08
• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-10-12
• Last Update Submitted: 2023-10-12
• Study First Posted: 2023-10-18
• Last Update Posted: 2023-10-18
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 18 and 80 years;
3. Stable vital signs;
4. Voluntary participation of family members with signed informed consent;
5. Good cooperation, minimal facial and spontaneous activities, no use of antiepileptic or sedative drugs.

Exclusion Criteria

1. Locked-in syndrome;
2. Contraindications for EEG examination;
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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DoC patients	Facial expression; Electroencephalogram; MRI	Patients with disorders of consciousness.
Healthy controls	Facial expression; Electroencephalogram; MRI	Healthy participants matched by gender and age.

Primary Outcome Measures

Name	Time	Method
CRS-r score	six month	CRS-R a standardized neurobehavioral assessment measure designed for use in patients with disorders of consciousness. The scale is intended to be used to establish diagnosis, monitor behavioral recovery, predict outcome, and assess treatment effectiveness. The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level.
GOSE score	six month	GOS-E is an extended version of the Glasgow Outcome Scale (GOS), which was developed to provide a more detailed assessment of patient functionality and quality of life after experiencing such an injury. It has eight categories: Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper Moderate Disability, Lower Good Recovery, and Upper Good Recovery

Trial Locations

Locations (1)

First Affiliated Hospital,Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China