Investigating the Localization of Consciousness Through Patients with Disorders of Consciousness: Anterior Vs. Posterior Cortex Debate

Exploring the Origin of Consciousness Through Disorders of Consciousness: a PET Study"

Patients enrolled in the study underwent five assessments using the CRS-R(Coma Recovery Scale-Revised) within 10 days, along with an 18F-FDG-PET scan.

Study Overview

• Status: Completed
• Conditions: Disorders of Consciousness

Detailed Description

Patients enrolled in the study underwent five assessments using the CRS-R (Coma Recovery Scale-Revised) within 10 days, along with an 18F-FDG-PET (18F-fluorodeoxyglucose-positron emission tomography) scan. The CRS-R evaluations were conducted by professionally trained and highly experienced personnel. During the CRS-R assessments, patients' behavioral responses were recorded in the domains of visual, auditory, motor, oromotor/verbal, communication, and arousal. Based on the optimal CRS-R results obtained within the 10-day period, patients were categorized into MCS (Minimally consciousness state, criteria: consistent command-following, reproducible responses to commands, object recognition, intelligible verbalization, partially accurate communication, object localization, visual pursuit and visual object localization, spontaneous motor responses, object manipulation, and/or localization to noxious stimulation) or UWS (Unresponsive wakefulness syndrome, criteria: preserved wakefulness accompanied by behavioral responses such as localization to sound, auditory startle, visual startle, withdrawal/flexion movements, abnormal posturing, vocalizations/oromotor movements, and reflexive oromotor responses). All patients exhibited stable vital signs. For data analysis, a healthy control group from Belgium was included to compare brain metabolism between patients with disorders of consciousness and healthy individuals.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • The enrolled patients were from Shanghai Yongci Rehabilitation Hospital, The Second People's Hospital of Hefei , and the First Affiliated Hospital, Zhejiang University school of Medicine.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The enrolled patients were from Shanghai Yongci Rehabilitation Hospital, The Second People's Hospital of Hefei , and the First Affiliated Hospital, Zhejiang University school of Medicine.

Description

Inclusion Criteria:

• Confirmed diagnosis of disorders of consciousness after 5 CRS-R assessments;
• Age >18 years;
• Stable vital signs;
• No use of sedatives or neuromuscular blockers within 24 hours prior to enrollment.

Exclusion Criteria:

• Acute-phase patients (injury duration <28 days);
• Fewer than 5 CRS-R assessments completed within 10 days;
• Patients diagnosed with EMCS (Emerging Minimally Conscious State);
• Patients with unclear diagnoses (cases where experienced evaluators could not reach a consensus diagnosis);
• Patients with persistent seizures.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
UWS (Unresponsive Wakefulness Syndrome); presence of basic arousal, localization to sound, auditory startle responses, visual startle responses, flexion withdrawal, abnormal posturing, vocalization/oromotor responses, and/or reflexive oromotor movements.
MCS (Minimally Conscious State); based on the following criteria: stable responses to commands, the ability to repeat commands, object recognition, understandable speech, incomplete communication, object localization, visual tracking, visual object localization, voluntary motor responses, manipulation of objects, and/or localization of noxious stimuli.
HC (Healthy control); people with full consciousness

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain metabolism in patients with disorders of consciousness was measured by 18F-FDG-PET	Patients were assessed using the CRS-R (Coma Recovery Scale-Revised) five times within 10 days, and an 18F-FDG-PET scan was performed. The assessors for the CRS-R evaluations were professionally trained and highly experienced. During the CRS-R assessment, the patients' behavioral performance in the areas of visual, auditory, motor, oromotor/speech, communication, and arousal were recorded. The patient's best CRS-R assessment score within the 10-day period was used to classify them into MCS (Minimally Conscious State) and UWS (Unresponsive Wakefulness Syndrome).	From enrollment to the end of CRS-R assessment in 10 days

Collaborators and Investigators

• Sponsor: Hangzhou Normal University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: December 31, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: PET; MCS; disorders of consciousness; UWS
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: 20230630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No