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Outcome Prediction in Patients With Acute Disorders of Consciousness

Prognosis of Acute DOC

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04411719
Enrollment
60
Registered
2020-06-02
Start date
2022-01-01
Completion date
2024-12-01
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Consciousness Disorder

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.

Interventions

None listed

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Glasgow Outcome Scale-Extended (GOS-E)Month 1GOS-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.

Countries

China

Contacts

Primary ContactBenyan Luo, Prof
luobenyan@zju.edu.cn0571-87236537

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026