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

Brain Injuries Clinical Trial

— DOCSIGNS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04687397
• Other study ID #: HN19025C73
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: April 24, 2020

Study information

• Verified date: December 2020
• Source: Hospitales Nisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 24, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Brain Injuries
• Consciousness Disorder
• Consciousness Disorders

Intervention

Behavioral:
• Rehabilitation
Multidisciplinary rehabilitation

Locations

Country	Name	City	State
Spain	Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Hospitales Nisa	Universitat Politècnica de València

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline score in the Coma Recovery Scale-Revised until study completion	The Coma Recovery Scale-Revised consists of 29 hierarchically organised items divided into 6 subscales addressing auditory, visual, motor, oromotor, communication, and arousal processes.	From inclusion in the study until discharge or death, assessed up to 24 months
Secondary	Change from baseline score in the Functional Independence Measure until study completion	The Functional Independence Measure is an 18-item measurement tool that explores an individual's physical, psychological and social function	From inclusion in the study until discharge or death, assessed up to 24 months
Secondary	Change from baseline score in the Disability Rating Scale until study completion	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	rom inclusion in the study until discharge or death, assessed up to 24 months