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

December 23, 2020 updated by: Enrique Noe, Hospitales Nisa

Investigation of the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46011
        • Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants were subjects who were diagnosed as with UWS or in a MCS after a brain injury

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Disorders of consciousness
Patients diagnosed as either in a Vegetative State or in a Minimally Conscious State
Behavioral: Rehabilitation
Multidisciplinary rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From inclusion in the study until discharge or death, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From inclusion in the study until discharge or death, assessed up to 24 months
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
rom inclusion in the study until discharge or death, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospitales Nisa

Collaborators

Universitat Politècnica de Valéncia

Investigators

  • Principal Investigator: Enrique Noé, Hospitales NISA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

April 24, 2020

Study Registration Dates

First Submitted

December 17, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 23, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN19025C73

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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