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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04687397
Acronym
DOCSIGNS
Enrollment
100
Registered
2020-12-29
Start date
2019-07-01
Completion date
2020-04-24
Last updated
2020-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Consciousness Disorder

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.

Interventions

BEHAVIORALRehabilitation

Multidisciplinary rehabilitation

Sponsors

Universitat Politècnica de València
CollaboratorOTHER
Hospitales Nisa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline score in the Coma Recovery Scale-Revised until study completionFrom inclusion in the study until discharge or death, assessed up to 24 monthsThe Coma Recovery Scale-Revised consists of 29 hierarchically organised items divided into 6 subscales addressing auditory, visual, motor, oromotor, communication, and arousal processes.

Secondary

MeasureTime frameDescription
Change from baseline score in the Functional Independence Measure until study completionFrom inclusion in the study until discharge or death, assessed up to 24 monthsThe 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 completionrom inclusion in the study until discharge or death, assessed up to 24 monthsThe 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026