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

NCT02879565 | Completed DMC

• 1 other identifier: REVE
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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:

• 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

Outcome Measures

Primary Outcomes (1)

• Perceptions of physicians and family members toward neuroimaging exams

  semi-structured interviews before the neuroimaging exams

  day one

Secondary Outcomes (1)

• Perceptions of physicians and family members of the neuroimaging exams results

  day seven

Study Arms (1)

qualitative and neuroimaging research

OTHER

Other: Semi structured interviews + EEG exams

Interventions

Semi structured interviews + EEG exams OTHER

qualitative and neuroimaging research

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Etablissement de rééducation fonctionnelle Les Salins de Bregille

Besançon, 25000, France

Location

Etablissement de rééducation fonctionnelle Bretégnier

Héricourt, 70400, France

Location

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Régis Aubry, Pr

  Centre Hospitalier Universitaire de Besancon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: August 25, 2016
• Study Start: September 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 25, 2016

Record last verified: 2016-08

Locations

FR (2)