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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Completed

CT.gov ID

NCT02879565

Collaborator

Etablissement de rééducation fonctionnelle Les Salins de Bregille (Other), Etablissement de rééducation fonctionnelle, Bretégnier (Other), Hôpital Local de Bussang (Other), University of Franche-Comté (Other)

Enrollment

Locations

Arm

17.1

Duration (Months)

6.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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:

Is it technically possible to generalize neuroimaging protocols to all healthcare institutions?
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

Condition or Disease	Intervention/Treatment	Phase
Disorders of Consciousness Qualitative Research Ethics Neuroimaging	Other: Semi structured interviews + EEG exams	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Other: qualitative and neuroimaging research

Other: Semi structured interviews + EEG exams

Outcome Measures

Primary Outcome Measures

Perceptions of physicians and family members toward neuroimaging exams [day one]
semi-structured interviews before the neuroimaging exams

Secondary Outcome Measures

Perceptions of physicians and family members of the neuroimaging exams results [day seven]
semi-structured interviews after the neuroimaging exams

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Etablissement de rééducation fonctionnelle Les Salins de Bregille	Besançon		France	25000
2	Etablissement de rééducation fonctionnelle Bretégnier	Héricourt		France	70400

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon
Etablissement de rééducation fonctionnelle Les Salins de Bregille
Etablissement de rééducation fonctionnelle, Bretégnier
Hôpital Local de Bussang
University of Franche-Comté

Investigators

Principal Investigator: Régis Aubry, Pr, Centre Hospitalier Universitaire de Besancon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT02879565

Other Study ID Numbers:

REVE

First Posted:

Aug 25, 2016

Last Update Posted:

Aug 25, 2016

Last Verified:

Aug 1, 2016

Additional relevant MeSH terms:

Consciousness Disorders

Study Results

No Results Posted as of Aug 25, 2016