Micro-movements in Patients With Prolonged Disorders of Consciousness

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

The goal of this observational study is to learn about the micro-movements in patients with prolonged disorders of consciousness. The main questions it aims to answer are:

Use the neuropsychological paradigm model to monitor micro-movements, assess the patient's remaining level of consciousness and accurately classify it; screen out patients with cognitive-motor dissociation to improve the prognosis of cognitive function; explore the remaining brain function of patients with chronic disorders of consciousness and promote relevant study of neural mechanisms.

Participants will be subjected to consciousness assessment by CRS-r scale, and their micro-movement 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial population

Patients are recruited from both general hospitals and rehabilitation hospitals.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • micro-movement; electroencephalogram; MRI

    Diagnostic test

    micro-movement; electroencephalogram; MRI

Treatment groups

179 Participants
are divided into 2 treatment groups
Group A: DoC patients1 intervention
Group B: healthy controls1 intervention

Trial outcomes

Primary outcomes

1

GOSE score

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.

Time frame
six months

Secondary outcomes

1

CRS-R score

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.

Time frame
six months

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

First Affiliated Hospital,Zhejiang UniversityRecruiting310003, Hanzhou, ZhejiangChinaChina

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Zhejiang University

Lead sponsor

Hangzhou Mingzhou Brain Rehabilitation Hospital

Collaborator

Zhejiang Provincial Armed Police Corps Hospital

Collaborator