Outcome Prediction in Patients With Acute Disorders of Consciousness

Prognosis of Acute DOC

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.

Study Overview

• Status: Recruiting
• Conditions: Consciousness Disorder
• Intervention / Treatment: Device: Electric stimulation device(Neuroconn)

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benyan Luo, Prof; Phone Number: 0571-87236537; Email: luobenyan@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University
      • Contact: Benyan Luo, Prof; Email: luobenyan@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Unresponsive patients after severe brain injury.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
EEG and Microexpression Analysis; Participants will be acutely unresponsive ICU patients. They will undergo non-invasive observational procedures, including EEG monitoring during exposure to emotional auditory stimuli, and concurrent video recording for microexpression analysis. Patient outcomes will be assessed at three, six, and twelve-month intervals post-initial observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Glasgow Outcome Scale-Extended (GOS-E)	GOSE will be assessed 3 months after brain injury.	Month 3
Glasgow Outcome Scale-Extended (GOS-E)	GOSE will be assessed 6 months after brain injury.	Month 6
Glasgow Outcome Scale-Extended (GOS-E)	GOSE will be assessed 12 months after brain injury.	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychological assessment	EEG indicators(i.e.,gamma oscillation, event-related potentials) are used to assess the consciousness level.	15 days

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Principal Investigator: Benyan Luo, Prof, Dr, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: Outcome in DOC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No