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

Completed

• Conditions: Disorders of Consciousness

• Registration Number: NCT06770348
• Lead Sponsor: Hangzhou Normal University

Brief Summary

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.

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 Timeline

• Study Start: 2021-04-01
• Status Verified: 2024-12
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30
• Study First Submitted: 2024-12-31
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain metabolism in patients with disorders of consciousness was measured by 18F-FDG-PET	From enrollment to the end of CRS-R assessment in 10 days	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).

Trial Locations

Locations (1)

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.; 🇨🇳 Shanghai, Shanghai, China