Micro-expressions in Patients With Prolonged Disorders of Consciousness

Status Recruiting

Clinical Trial Summary

The goal of this observational study is to learn about the microexpressions in patients with prolonged disorders of consciousness. The main questions it aims to answer are: - Inducing micro-expression changes in patients with prolonged disorders of consciousness through various emotional stimuli, and further to achieve precise classification of their levels of consciousness. - Detecting micro-expressions in patients with prolonged disorders of consciousness to assist clinical diagnosis of levels of consciousness, e.g., complement the disgnosis of clinical scales such as CRS-r scale. - By monitoring micro-expression changes in patients with prolonged disorders of consciousness, researchers can explore their residual brain function, thereby advancing research into relevant neural mechanisms. Participants will be subjected to consciousness assessment by CRS-r scale, and their micro-expression 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.

Clinical Trial Description

In accordance with the inclusion and exclusion criteria, a total of about 200 participants will be recruited, including about 150 confirmed cases of prolonged disorders of consciousness and 50 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-expression 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

Related Conditions & MeSH terms

Consciousness Disorders

Clinical Trial Details

NCT number	NCT06088628
Study type	Observational [Patient Registry]
Source	First Affiliated Hospital of Zhejiang University
Contact	Fangping He, Master
Phone	86-13819114225
Email	hefangping@zju.edu.cn
Status	Recruiting
Phase
Start date	June 27, 2022
Completion date	December 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02667899` - The Consciousness Variation of Deep Brain and Transcranial Magnetic Stimulation for Disorders of Consciousness Patients	N/A
Completed	`NCT03060317` - Validation of the Russian Version of Coma Recovery Scale-Revised (CRS-R)	N/A
Not yet recruiting	`NCT06389344` - Effect of Esketamine on Conscious State in Patients With pDoC	N/A
Terminated	`NCT02522429` - Thalamic Low Intensity Focused Ultrasound in Brain Injury	N/A
Completed	`NCT02772302` - Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome	N/A
Recruiting	`NCT02714491` - Effects of Auditory Stimulation During Verticalization With Erigo in Patients With Disorder of Consciousness	N/A
Terminated	`NCT03367078` - tDCS in Patients With Disorder of Consciousness Due to Severe Acquired Brain Injury
Completed	`NCT02828371` - Early Stepping Verticalization in ICU for ABI Patients	N/A
Recruiting	`NCT06211439` - Transcranial Alternating Current Stimulation in Patients With Disorders of Consciousness	N/A
Not yet recruiting	`NCT02659228` - Assessing Covert Consciousness in Unresponsive Patients	N/A
Completed	`NCT00700869` - Evaluation of a New Mechanical Ventilation Weaning Strategy for Patients With Altered Level of Consciousness	Phase 2/Phase 3
Recruiting	`NCT02644265` - CONNECT-ME: Consciousness in Neurocritical Care Cohort Study Using fMRI and EEG
Completed	`NCT01141790` - Analysis of Vital, Facial and Muscular Responses Front to Music or Message in Coma, Vegetative State or Sedated Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.