Micro-movements in Patients With Prolonged Disorders of Consciousness

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

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.

Study Overview

• Status: Recruiting
• Conditions: Consciousness Disorders
• Intervention / Treatment: Diagnostic test: micro-movement; electroencephalogram; MRI

Detailed Description

In accordance with the inclusion and exclusion criteria, a total of about 178 participants will be recruited, including about 89 confirmed cases of prolonged disorders of consciousness and 89 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-movement 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 Type: Observational
• Enrollment (Estimated): 179

Contacts and Locations

• Study Contact: Name: Zhuolin He; Phone Number: 15990049962; Email: hezhuolin@zju.edu.cn
• Study Contact Backup: Name: Benyan Luo; Email: luobenyan@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hanzhou, Zhejiang, China, 310003
      • Recruiting
      • First Affiliated Hospital,Zhejiang University
      • Principal Investigator: Benyan Luo, Phd
      • Contact: Zhuolin He, BA; Phone Number: 15990049962; Email: hezhuolin@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients are recruited from both general hospitals and rehabilitation hospitals.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DoC patients; patients with disorders of consciousness	Diagnostic test: micro-movement; electroencephalogram; MRI; micro-movement; electroencephalogram; MRI
healthy controls; healthy participants matched by gender and age	Diagnostic test: micro-movement; electroencephalogram; MRI; micro-movement; electroencephalogram; MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	six months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborators: Hangzhou Mingzhou Brain Rehabilitation Hospital; Zhejiang Provincial Armed Police Corps Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: disorders of consciousness; consciousness; consciousness disorders; micro-movement; Multidimensional paradigm stimulation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Consciousness Disorders; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Diagnostic Techniques, Neurological; Electrodiagnosis; Magnetic Resonance Imaging; Electroencephalography
• Other Study ID Numbers: Micro-movement

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No