Outcome Prediction in Patients With Acute Disorders of Consciousness

Consciousness Disorder Clinical Trial

Official title:

Prognosis of Acute DOC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04411719
• Other study ID #: Outcome in DOC
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Benyan Luo, Prof
• Phone: 0571-87236537
• Email: luobenyan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prior research has indicated a link between outcomes in patients with disorders of consciousness (DOC) and their responses to emotional auditory stimuli. Given the high degree of uncertainty in acute situations, this study plans to record EEG responses and observe microexpressions in DOC patients during exposure to auditory stimuli, with the aim to identify more reliable prognostic indicators. The goal is to uncover potential patterns or signals that can contribute to a more comprehensive understanding of a patient's condition, and thereby provide more accurate prognostication.

Description:

This study intends to probe the potential of electroencephalography (EEG) and microexpression analysis for predicting the outcomes of acutely unresponsive patients within the intensive care unit (ICU). Previous research has illuminated a relationship between patients' emotional responses to auditory stimuli and their prognosis. However, the predictive utility of these responses in the context of acute conditions remains largely unexplored.

At the onset of the study, participants will undergo EEG monitoring while exposed to a pre-determined set of emotional auditory stimuli. Additionally, the patients' facial expressions will be captured via video for subsequent microexpression analysis.

Follow-up assessments of the patients' status will be conducted at three, six, and twelve-month intervals. Using cutting-edge analytical techniques, the goal is to decode these EEG and microexpression responses. This study aims to identify possible correlations between these findings, the patients' diagnoses, and their respective outcomes over time.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with acute brain injury (<28 days) in ICU

• GCS = 8

• = 2 days after sedation

• Normal hearing, with auditory startle reflex

Exclusion Criteria:

• Children under 18

Related Conditions & MeSH terms

• Consciousness Disorder
• Consciousness Disorders

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Outcome Scale-Extended (GOS-E)	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.	Month 1
Primary	Glasgow Outcome Scale-Extended (GOS-E)	GOSE will be assessed 3 months after brain injury.	Month 3
Primary	Glasgow Outcome Scale-Extended (GOS-E)	GOSE will be assessed 6 months after brain injury.	Month 6
Primary	Glasgow Outcome Scale-Extended (GOS-E)	GOSE will be assessed 12 months after brain injury.	Month 12