Clinical Trials Logo

Clinical 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 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06406413
Study type Observational
Source First Affiliated Hospital of Zhejiang University
Contact Zhuolin He
Phone 15990049962
Email hezhuolin@zju.edu.cn
Status Recruiting
Phase
Start date May 1, 2024
Completion date December 2026

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 NCT06088628 - Micro-expressions in Patients With Prolonged Disorders of Consciousness
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