Micro-movements in Patients With Prolonged Disorders of Consciousness

NCT ID: NCT06406413

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 179 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-12-31

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.

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.

Conditions

Consciousness Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

DoC patients

patients with disorders of consciousness

micro-movement; electroencephalogram; MRI

Intervention Type: DIAGNOSTIC_TEST

micro-movement; electroencephalogram; MRI

healthy controls

healthy participants matched by gender and age

micro-movement; electroencephalogram; MRI

Intervention Type: DIAGNOSTIC_TEST

micro-movement; electroencephalogram; MRI

Interventions

micro-movement; electroencephalogram; MRI

micro-movement; electroencephalogram; MRI

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hangzhou Mingzhou Brain Rehabilitation Hospital

UNKNOWN

Sponsor Role: collaborator

Zhejiang Provincial Armed Police Corps Hospital

UNKNOWN

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital,Zhejiang University

Hanzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhuolin He

Role: CONTACT

hezhuolin@zju.edu.cn

15990049962

Benyan Luo

Role: CONTACT

luobenyan@zju.edu.cn

Facility Contacts

Zhuolin He, BA

Role: primary

hezhuolin@zju.edu.cn

15990049962

Other Identifiers

Micro-movement

Identifier Type: -

Identifier Source: org_study_id