Behavioral Signs of Consciousness Recovery in Patients With Disorders of Consciousness (DOCSIGNS)

Completed

• Conditions: Consciousness Disorder; Brain Injuries
• Interventions: Behavioral: Rehabilitation

• Registration Number: NCT04687397
• Lead Sponsor: Hospitales Nisa

Brief Summary

Precise description of behavioral signs denoting transition from unresponsive wakefulness syndrome/vegetative state (UWS/VS) to minimally conscious state (MCS) or emergence from MCS after severe brain injury is crucial for prognostic purposes. A few studies have attempted this goal but involved either non-standardized instruments, limited temporal accuracy or samples, or focused on (sub)acute patients. The objective of this study is to describe the behavioral signs that led to a change of diagnosis, as well as the factors influencing this transition, in a large sample of patients with chronic disorders of consciousness after severe brain injury.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-04-24
• Status Verified: 2020-12
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-23
• Last Update Submitted: 2020-12-23
• Study First Posted: 2020-12-29
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• documented medical diagnosis of CRS-R-based diagnosis of UWS or MCS at admission to the neurorehabilitation program

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Disorders of consciousness	Rehabilitation	Patients diagnosed as either in a Vegetative State or in a Minimally Conscious State

Primary Outcome Measures

Name	Time	Method
Change from baseline score in the Coma Recovery Scale-Revised until study completion	From inclusion in the study until discharge or death, assessed up to 24 months	The Coma Recovery Scale-Revised consists of 29 hierarchically organised items divided into 6 subscales addressing auditory, visual, motor, oromotor, communication, and arousal processes.

Secondary Outcome Measures

Name	Time	Method
Change from baseline score in the Disability Rating Scale until study completion	rom inclusion in the study until discharge or death, assessed up to 24 months	The Disability Rating Scale is an 8-item measure that assesses disability of individuals with moderate to severe traumatic brain injury at a wide range of functional levels from coma through community living
Change from baseline score in the Functional Independence Measure until study completion	From inclusion in the study until discharge or death, assessed up to 24 months	The Functional Independence Measure is an 18-item measurement tool that explores an individual's physical, psychological and social function

Trial Locations

Locations (1)

Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA; 🇪🇸 Valencia, Spain