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

NCT ID: NCT02879565

Last Updated: 2016-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-02-28

Brief Summary

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

Conditions

Disorders of Consciousness; Qualitative Research; Ethics; Neuroimaging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

qualitative and neuroimaging research

Group Type: OTHER

Semi structured interviews + EEG exams

Intervention Type: OTHER

Interventions

Semi structured interviews + EEG exams

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Etablissement de rééducation fonctionnelle Les Salins de Bregille

UNKNOWN

Sponsor Role: collaborator

Etablissement de rééducation fonctionnelle, Bretégnier

UNKNOWN

Sponsor Role: collaborator

Hôpital Local de Bussang

UNKNOWN

Sponsor Role: collaborator

University of Franche-Comté

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Régis Aubry, Pr

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Besancon

Locations

Etablissement de rééducation fonctionnelle Les Salins de Bregille

Besançon, , France

Etablissement de rééducation fonctionnelle Bretégnier

Héricourt, , France

Countries

France

Other Identifiers

REVE

Identifier Type: -

Identifier Source: org_study_id