Micro-expressions in Patients With Prolonged Disorders of Consciousness

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06088628
Collaborator
(none)
200
1
53.2
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Facial expression; Electroencephalogram; MRI

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Study of Micro-expressions in Patients With Prolonged Disorders of Consciousness
Actual Study Start Date :
Jun 27, 2022
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
DoC patients

Patients with disorders of consciousness.

Diagnostic Test: Facial expression; Electroencephalogram; MRI
Recording facial expressions of participants, EEG recordings, and MRI scans.

Healthy controls

Healthy participants matched by gender and age.

Diagnostic Test: Facial expression; Electroencephalogram; MRI
Recording facial expressions of participants, EEG recordings, and MRI scans.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affiliated Hospital,Zhejiang University Hangzhou Zhejiang China 310003

Sponsors and Collaborators

  • First Affiliated Hospital of Zhejiang University

Investigators

  • Principal Investigator: Benyan Luo, Doctor, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier:
NCT06088628
Other Study ID Numbers:
  • Micro-expression
First Posted:
Oct 18, 2023
Last Update Posted:
Oct 18, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by First Affiliated Hospital of Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2023