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

Disorders of Consciousness Clinical Trial

— REVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879565
• Other study ID #: REVE
• Status: Completed
• Phase: N/A
• First received: July 18, 2016
• Last updated: August 22, 2016
• Start date: September 2011
• Est. completion date: February 2013

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Health PRoduct Safety AgencyFrance: Comittee for Protection of Persons
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorders of Consciousness
• Ethics
• Neuroimaging
• Qualitative Research

Intervention

Other:
• Semi structured interviews + EEG exams

Locations

Country	Name	City	State
France	Etablissement de rééducation fonctionnelle Les Salins de Bregille	Besançon
France	Etablissement de rééducation fonctionnelle Bretégnier	Héricourt

Sponsors (5)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceptions of physicians and family members toward neuroimaging exams	semi-structured interviews before the neuroimaging exams	day one	No
Secondary	Perceptions of physicians and family members of the neuroimaging exams results	semi-structured interviews after the neuroimaging exams	day seven	No