Behavioral Signs of Consciousness Recovery in Patients With Disorders of Consciousness (DOCSIGNS)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Disorders of consciousness Patients diagnosed as either in a Vegetative State or in a Minimally Conscious State |
Behavioral: Rehabilitation
Multidisciplinary rehabilitation
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- documented medical diagnosis of CRS-R-based diagnosis of UWS or MCS at admission to the neurorehabilitation program
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA | Valencia | Spain | 46011 |
Sponsors and Collaborators
- Hospitales Nisa
- Universitat Politècnica de València
Investigators
- Principal Investigator: Enrique Noé, Hospitales Nisa
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HN19025C73