An observational study in Consciousness Disorders, sponsored by First Affiliated Hospital of Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by First Affiliated Hospital of Zhejiang University · Observational
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.
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.
236 studies on the registry are indexed under Consciousness Disorders; 102 are open to participants now.
This study's planned enrollment of 179 is above the median of 79 across 86 observational studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients are recruited from both general hospitals and rehabilitation hospitals.
Exclusion Criteria:
patients with disorders of consciousness
Diagnostic Test: micro-movement; electroencephalogram; MRI
healthy participants matched by gender and age
Diagnostic Test: micro-movement; electroencephalogram; MRI
micro-movement; electroencephalogram; MRI
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
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
Plan to share: Undecided
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First Affiliated Hospital of Zhejiang University