Consciousness DisordersNCT06406413
Micro-movements in Patients With Prolonged Disorders of Consciousness
An observational study of Consciousness Disorders, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Consciousness Disorders
- What is being tested?
- micro-movement; electroencephalogram; MRI
- How many people
- 179 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are recruited from both general hospitals and rehabilitation hospitals.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Benyan Luo contact
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital,Zhejiang University
Hanzhou, Zhejiang, 310003
Zhuolin He, BA, 15990049962, hezhuolin@zju.edu.cn
Benyan Luo, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- micro-movement; electroencephalogram; MRI
- Keywords
- disorders of consciousness, consciousness disorders, micro-movement, consciousness, Multidimensional paradigm stimulation
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-movement; electroencephalogram; MRIDiagnostic test
micro-movement; electroencephalogram; MRI
| Study group | Role | What they receive |
|---|---|---|
| DoC patients | patients with disorders of consciousness Receives: Diagnostic Test: micro-movement; electroencephalogram; MRI | |
| healthy controls | healthy participants matched by gender and age Receives: Diagnostic Test: micro-movement; electroencephalogram; MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consciousness DisordersStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 179 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Mingzhou Brain Rehabilitation Hospital, Zhejiang Provincial Armed Police Corps Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406413
- Sponsor's protocol ID
- Micro-movement
- Status last verified
- Nov 2025
- First submitted
- 6 May 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Micro-movements in Patients With Prolonged Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT06406413
- Acronym / sponsor ID
- Micro-movement
- Conditions
- Consciousness Disorders
- Keywords
- disorders of consciousness, consciousness disorders, micro-movement, consciousness, Multidimensional paradigm stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 179 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Mingzhou Brain Rehabilitation Hospital, Zhejiang Provincial Armed Police Corps Hospital
- Study start
- 1 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DoC patients | – | Diagnostic Test: micro-movement; electroencephalogram; MRIpatients with disorders of consciousness |
| healthy controls | – | Diagnostic Test: micro-movement; electroencephalogram; MRIhealthy participants matched by gender and age |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited from both general hospitals and rehabilitation hospitals.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micro-movement; electroencephalogram; MRImicro-movement; electroencephalogram; MRI | Diagnostic test | DoC patients, healthy controls |
Primary outcome
GOSE score
Time frame: six months
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.
1 secondary outcome
CRS-R score
Time frame: six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benyan Luo contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Consciousness Disorders, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhuolin He (15990049962, hezhuolin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GOSE score (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.