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Completed

NCT Number: NCT04687397

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

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.

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Key information

Conditions

Consciousness Disorder Brain Diseases Brain Injuries Central Nervous System Diseases Consciousness Disorders Craniocerebral Trauma Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA

Valencia, 46011, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Rehabilitation

Behavioral

Multidisciplinary rehabilitation

Primary outcomes

  1. Change from baseline score in the Coma Recovery Scale-Revised until study completion

    Time frame: 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 outcomes

  1. Change from baseline score in the Functional Independence Measure until study completion

    Time frame: 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

  2. Change from baseline score in the Disability Rating Scale until study completion

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospitales Nisa

Other

Collaborators

  • Universitat Politècnica de València

Registry information

Official study title

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

Acronym: DOCSIGNS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 29, 2020
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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