Status:
COMPLETED
Validation of the Chinese Version of the SECONDs
Lead Sponsor:
Hangzhou Normal University
Conditions:
Minimally Conscious State
Vegetative State
Eligibility:
All Genders
16-75 years
Phase:
NA
Brief Summary
The aim of this study was to translate the SECONDs from English into Chinese and determine the validity of this Chinese version
Detailed Description
The assessment is of great importance for the management and treatment in patients with disorders of consciousness. The Simplified Evaluation of CONsciousness Disorders is a useful tool to assess cons...
Eligibility Criteria
Inclusion
- age ≥ 16 years old;
- no administration of neuromuscular blockers or sedation within the 24 hours of enrolment;
- the presence of periods of eye opening (indicating wakefulness and rest cycles);
- a diagnosis of VS or MCS, based on more than 4 times behavioral assessment performed using the Coma Recovery Scale-Revised within 2 weeks.
Exclusion
- Coma;
- documented history of prior brain injury;
- psychiatric or neurologic illness;
- neuromuscular blocking agents or sedative drugs administered within the prior 24 hours;
- no documented history of a prior coma, critical illness or unstable medical condition;
- upper limb contusions, fractures (based on the imaging examination) or flaccid paralysis (by using noxious stimuli to upper limbs, motor sub-scale scores \<1).
Key Trial Info
Start Date :
November 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04687553
Start Date
November 10 2020
End Date
July 1 2021
Last Update
July 8 2022
Active Locations (1)
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1
International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
Hangzhou, Zhejiang, China, 310036