Outcome Prediction in Patients With Acute Disorders of Consciousness

NCT ID: NCT04411719

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-12-01

Brief 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.

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.

Conditions

Consciousness Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benyan Luo, Prof, Dr

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Benyan Luo, Prof

Role: CONTACT

luobenyan@zju.edu.cn

0571-87236537

Facility Contacts

Benyan Luo, Prof

Role: primary

luobenyan@zju.edu.cn

Other Identifiers

Outcome in DOC

Identifier Type: -

Identifier Source: org_study_id