Families Expectations and Hope Raised by an Evaluation of Consciousness in Patients in a Vegetative State (REVE)

Families Expectations and Hope Raised by an Evaluation of Consciousness in Patients With an Unresponsive Wakefulness Syndrome

Progress in resuscitation has increased the chances of survival after anoxic or traumatic brain injury. More and more patients with severe cerebral damages are resuscitated but upon awakening from coma, some patients remain in a state which cannot be qualified as conscious and is now known as an unresponsive wakefulness syndrome (UWS; formerly known as vegetative state). This condition can be transitory and evolve towards recovery, or remain chronic and lasting for years.

To improve the diagnosis of patients with disorders of consciousness, recent advances in brain imaging have led to the development of new methods of detecting awareness. In the absence of overt behavioral responses from these patients, imaging-based diagnostic methods have been first used to assess whether some cerebral areas were preserved in UWS patients and showed an activation of the primary sensory cortices in some UWS patients, whether it occurs at the auditory, visual or somatosensory level. Unavoidable technical and ethical issues are raised for clinicians before responding to such requests:

1. Is it technically possible to generalize neuroimaging protocols to all healthcare institutions?
2. Is it ethically acceptable to propose neuroimaging protocols without an accurate estimation of their psychological impact on families and caregivers?

The present study aims to understand and anticipate the technical and ethical issues related to an evaluation of consciousness with functional neuroimaging. How the evaluation of awareness in a patient affects the caregivers and family members will be investigated. By using qualitative research hopes and expectations will be clarified through the experiences of families, clinicians and nurses faced to this situation.

Will be included in this research professional caregivers and persons closely related to UWS patients:

• Family members or close circle visiting the patients on a regular basis
• Referring clinicians
• Nurses in charge of the patients' care

This prospective study uses qualitative, interview-based, research. Two key-moments are explored in succession to examine the impact of a neuroimaging evaluation of consciousness in institutionalized UWS patients:

• interviews of professional caregivers and families about their hopes concerning the evaluation of consciousness of UWS patients,
• interviews of professional caregivers and families about the impact of evaluating consciousness on their beliefs

Study Overview

• Status: Completed
• Conditions: Disorders of Consciousness; Neuroimaging; Qualitative Research; Ethics
• Intervention / Treatment: Other: Semi structured interviews + EEG exams

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • Etablissement de rééducation fonctionnelle Les Salins de Bregille
  • Héricourt, France, 70400
    • Etablissement de rééducation fonctionnelle Bretégnier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult family members, clinicians, nurses (aged >18 years) closely related to UWS patients
• patients diagnosed as being in an UWS

Exclusion Criteria:

• patients in a minimally conscious state, in a locked-in-syndrome of akinetic mutism
• refusal of family members, clinicians or nurses to participate to the study
• family members considered by clinicians not to be capable of passing the interviews
• subjects aged < 18 years
• non french speaking subjects

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: qualitative and neuroimaging research	Other: Semi structured interviews + EEG exams

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceptions of physicians and family members toward neuroimaging exams	semi-structured interviews before the neuroimaging exams	day one

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceptions of physicians and family members of the neuroimaging exams results	semi-structured interviews after the neuroimaging exams	day seven

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besançon
• Collaborators: University of Franche-Comté; Etablissement de rééducation fonctionnelle Les Salins de Bregille; Etablissement de rééducation fonctionnelle, Bretégnier; Hôpital Local de Bussang
• Investigators: Principal Investigator: Régis AUBRY, Pr, Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Estimate): August 25, 2016
• Last Update Submitted That Met QC Criteria: August 22, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: REVE