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

NCT ID: NCT04687397

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-04-24

Brief Summary

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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

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Conditions

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Consciousness Disorder Brain Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Disorders of consciousness

Patients diagnosed as either in a Vegetative State or in a Minimally Conscious State

Rehabilitation

Intervention Type BEHAVIORAL

Multidisciplinary rehabilitation

Interventions

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Rehabilitation

Multidisciplinary rehabilitation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat Politècnica de València

OTHER

Sponsor Role collaborator

Hospitales Nisa

OTHER

Sponsor Role lead

Responsible Party

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Enrique Noe

Research director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enrique Noé

Role: PRINCIPAL_INVESTIGATOR

Hospitales Nisa

Locations

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Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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HN19025C73

Identifier Type: -

Identifier Source: org_study_id