Study of Micro-movements in Patients With Prolonged Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- GOSE score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
DoC patients
patients with disorders of consciousness
干预措施: micro-movement; electroencephalogram; MRI (Diagnostic Test)
healthy controls
healthy participants matched by gender and age
干预措施: micro-movement; electroencephalogram; MRI (Diagnostic Test)
结局指标
主要结局
GOSE score
时间窗: 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.
次要结局
- CRS-R score(six months)