Clinical trial NCT06770348: Investigating the Localization of Consciousness Through Patients with Disorders of Consciousness: Anterior Vs. Posterior Cortex Debate
Official title: Exploring the Origin of Consciousness Through Disorders of Consciousness: a PET Study"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorders of Consciousness
Keywords: disorders of consciousness
MCS
PET
UWS
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Brain metabolism in patients with disorders of consciousness was measured by 18F-FDG-PET
timeFrame: From enrollment to the end of CRS-R assessment in 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 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.
state: Shanghai
Study officials:
References: