Micro-movements in Patients With Prolonged Disorders of Consciousness

NCT06406413 | Recruiting

• 1 other identifier: Micro-movement
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Consciousness Disorders

Keywords

disorders of consciousness; consciousness disorders; micro-movement; consciousness; Multidimensional paradigm stimulation

Outcome Measures

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.

  six months

Secondary Outcomes (1)

• CRS-R score

  six months

Study Arms (2)

DoC patients

patients with disorders of consciousness

Diagnostic Test: micro-movement; electroencephalogram; MRI

healthy controls

healthy participants matched by gender and age

Diagnostic Test: micro-movement; electroencephalogram; MRI

Interventions

micro-movement; electroencephalogram; MRI DIAGNOSTIC_TEST

micro-movement; electroencephalogram; MRI

DoC patients; healthy controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients are recruited from both general hospitals and rehabilitation hospitals.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Hangzhou Mingzhou Brain Rehabilitation Hospital: collaborator
• Zhejiang Provincial Armed Police Corps Hospital: collaborator

Study Sites (1)

First Affiliated Hospital,Zhejiang University

Hanzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Electroencephalography; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Tomography; Diagnostic Imaging

Central Study Contacts

Zhuolin He

CONTACT

15990049962; hezhuolin@zju.edu.cn

Benyan Luo

CONTACT

luobenyan@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2025-11

Locations

CN (1)