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

NCT04687397 | Completed

• 1 other identifier: HN19025C73
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Consciousness Disorder; Brain Injuries

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• 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

• 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

Study Arms (1)

Disorders of consciousness

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

Behavioral: Rehabilitation

Interventions

Rehabilitation BEHAVIORAL

Multidisciplinary rehabilitation

Disorders of consciousness

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Hospitales Nisa: lead
• Universitat Politècnica de València: collaborator

Study Sites (1)

Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA

Valencia, 46011, Spain

Location

MeSH Terms

Conditions

Consciousness Disorders; Brain Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Enrique Noé

  Hospitales Nisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research director

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 29, 2020
• Study Start: July 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: April 24, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

ES (1)