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

NCT06770348 | Completed

• 1 other identifier: 20230630
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorders of Consciousness

Keywords

disorders of consciousness; MCS; PET; UWS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Normal University: lead

Study Sites (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 Municipality, China

Location

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 Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 13, 2025
• Study Start: April 1, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 13, 2025

Record last verified: 2024-12

Locations

CN (1)