Disorders of ConsciousnessREVENCT02879565
Families Expectations and Hope Raised by an Evaluation of Consciousness in Patients in a Vegetative State
A study testing Semi structured interviews + EEG exams in people with Disorders of Consciousness and Qualitative Research, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disorders of Consciousness, Qualitative Research, Ethics
- What is being tested?
- Semi structured interviews + EEG exams
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult family members, clinicians, nurses (aged >18 years) closely related to UWS patients
- patients diagnosed as being in an UWS
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Etablissement de rééducation fonctionnelle Les Salins de Bregille
Besançon, 25000
Etablissement de rééducation fonctionnelle Bretégnier
Héricourt, 70400
About this study
Official title: 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:
Read more
- 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
- Conditions
- Disorders of Consciousness, Qualitative Research, Ethics, Neuroimaging
- Being tested
- Semi structured interviews + EEG exams
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi structured interviews + EEG examsOther
| Study group | Role | What they receive |
|---|---|---|
| qualitative and neuroimaging research | Other | Not described Receives: Other: Semi structured interviews + EEG exams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptions of physicians and family members toward neuroimaging exams
semi-structured interviews before the neuroimaging exams
Measured: day one
Secondary outcomes (1)
Perceptions of physicians and family members of the neuroimaging exams results
semi-structured interviews after the neuroimaging exams
Measured: day seven
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startSep 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Etablissement de rééducation fonctionnelle Les Salins de Bregille, Etablissement de rééducation fonctionnelle, Bretégnier, Hôpital Local de Bussang, University of Franche-Comté
- Responsible party
- Sponsor
- Investigators
- Régis Aubry, Pr, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879565
- Sponsor's protocol ID
- REVE
- Acronym
- REVE
- Status last verified
- Aug 2016
- First submitted
- 18 Jul 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families Expectations and Hope Raised by an Evaluation of Consciousness in Patients With an Unresponsive Wakefulness Syndrome
- ClinicalTrials.gov ID
- NCT02879565
- Acronym / sponsor ID
- REVE / REVE
- Conditions
- Disorders of Consciousness, Qualitative Research, Ethics, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Etablissement de rééducation fonctionnelle Les Salins de Bregille, Etablissement de rééducation fonctionnelle, Bretégnier, Hôpital Local de Bussang, University of Franche-Comté
- Study start
- Sep 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| qualitative and neuroimaging research | Other | Other: Semi structured interviews + EEG exams |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult family members, clinicians, nurses (aged >18 years) closely related to UWS patients
- patients diagnosed as being in an UWS
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi structured interviews + EEG exams | Other | qualitative and neuroimaging research |
Primary outcome
Perceptions of physicians and family members toward neuroimaging exams
Time frame: day one
semi-structured interviews before the neuroimaging exams
1 secondary outcome
Perceptions of physicians and family members of the neuroimaging exams results
Time frame: day seven
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Régis Aubry, Pr principal investigator
Centre Hospitalier Universitaire de Besancon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi structured interviews + EEG exams in people with Disorders of Consciousness and Qualitative Research, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceptions of physicians and family members toward neuroimaging exams (time frame: day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.