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NCT Number: NCT06088628

Micro-expressions in Patients With Prolonged Disorders of Consciousness

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital,Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location status: Recruiting

Location contact

Benyan Luo, PhD

CONTACT

[email protected]

86-13967166677

Benyan Luo, Phd

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Facial expression; Electroencephalogram; MRI

Diagnostic Test

Recording facial expressions of participants, EEG recordings, and MRI scans.

Primary outcomes

  1. GOSE score

    Time frame: 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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fangping He, Master

CONTACT

[email protected]

86-13819114225

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Collaborators

  • Hangzhou Mingzhou Brain Rehabilitation Hospital
  • Zhejiang Provincial Armed Police Corps Hospital
  • Zhejiang Provincial People's Hospital

Registry information

Official study title

Study of Micro-expressions in Patients With Prolonged Disorders of Consciousness

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2023
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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