Outcome Prediction in Patients With Acute Disorders of Consciousness

NCT04411719 | Unknown DMC

• 1 other identifier: Outcome in DOC
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Consciousness Disorder

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Unresponsive patients after severe brain injury.

You may qualify if:

• Patients with acute brain injury (\<28 days) in ICU
• GCS ≤ 8
• ≥ 2 days after sedation
• Normal hearing, with auditory startle reflex

You may not qualify if:

• Children under 18

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Benyan Luo, Prof, Dr

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benyan Luo, Prof

CONTACT

0571-87236537; luobenyan@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 2, 2020
• Study Start: January 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)