An observational study in Disorders of Consciousness, sponsored by Hangzhou Normal University. Completed at 1 site in China. Open to participants aged 18 Years to 81 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by Hangzhou Normal University · Observational
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.
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.
290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.
This study's enrollment of 100 is above the median of 79 across 95 observational studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Hangzhou Normal University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
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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.
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Exclusion Criteria:
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.
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.
people with full consciousness
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).
Time frame: From enrollment to the end of CRS-R assessment in 10 days
Plan to share: Undecided
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Hangzhou Normal University