Clinical trial NCT04471753: Target Behaviours to Identify Minimally Conscious State Patients
Official title: Target Behaviours to Identify Minimally Conscious State Patients by Using Coma Recovery Scale-Revised
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Consciousness
Minimally Conscious State
Keywords: disorders of consciousness
Coma Recovery Scale-revision
minimally conscious state
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients were assessed by the Coma Recovery Scale-Revised for several times with seven days.

Brief summary: To analyse the frequency of the consciousness behaviour response for patients with minimally conscious state of Coma Recovery Scale-Revised items, as well as the necessary items for obtaining higher accuracy. In addition, providing target behaviours for Coma Recovery Scale-Revised assessment of minimally conscious state diagnosis and evidence for the simplification of Coma Recovery Scale-Revised in the future.

Detailed description: Data were collected according to the Coma Recovery Scale-Revised operation guideline, the sum of the highest score on the evaluated subscales was taken as the final score, and the final diagnosis of patients was obtained (the highest score of each subscale was recorded). All participants were diagnosed by using Coma Recovery Scale-Revised five times at least within 7 days. According to the results of the Coma Recovery Scale-Revised assessment, minimally conscious state and unresponsive wakefulness syndrome patients were distinguished.

Eligibility criteria: Inclusion Criteria:

* Patients with medical diagnosis of prolonged disorders of consciuosness (≥28 days) were included in neurosurgery, neurology, and neurorehabilitation units.

Exclusion Criteria:

* Patients who used neuromuscular blockers or sedatives within 72 hours of enrolment were excluded.

Primary outcomes:
measure: Coma Recovery Scale-Revised
timeFrame: Within 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
state: Zhejiang
Study officials:
affiliation: Hangzhou Normal University
name: Haibo Di, Pro.
role: STUDY_CHAIR
References:
citation: Wannez S, Heine L, Thonnard M, Gosseries O, Laureys S; Coma Science Group collaborators. The repetition of behavioral assessments in diagnosis of disorders of consciousness. Ann Neurol. 2017 Jun;81(6):883-889. doi: 10.1002/ana.24962.
citation: American Congress of Rehabilitation Medicine, Brain Injury-Interdisciplinary Special Interest Group, Disorders of Consciousness Task Force; Seel RT, Sherer M, Whyte J, Katz DI, Giacino JT, Rosenbaum AM, Hammond FM, Kalmar K, Pape TL, Zafonte R, Biester RC, Kaelin D, Kean J, Zasler N. Assessment scales for disorders of consciousness: evidence-based recommendations for clinical practice and research. Arch Phys Med Rehabil. 2010 Dec;91(12):1795-813. doi: 10.1016/j.apmr.2010.07.218.