Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406413
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-06
Brief Title:
Micro-movements in Patients With Prolonged Disorders of Consciousness
Sponsor:
First Affiliated Hospital of Zhejiang University
Organization:
First Affiliated Hospital of Zhejiang University
Study Overview
Official Title:
Study of Micro-movements in Patients With Prolonged Disorders of Consciousness
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
Use the neuropsychological paradigm model to monitor micro-movements assess the patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None