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

NCT ID: NCT06770348

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2024-12-30

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.

Conditions

Disorders of Consciousness

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

HC (Healthy control)

people with full consciousness

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hangzhou Normal University

OTHER

Sponsor Role: lead

Responsible Party

Anqi Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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 Municipality, China

Countries

China

Other Identifiers

20230630

Identifier Type: -

Identifier Source: org_study_id