Consciousness DisorderREVEILNCT04978857
Feasibility Study of Virtual Reality to Promote the Awakening of Patients in a State of Minimal Consciousness
A study testing autobiographic movie in people with Consciousness Disorder, run by University Hospital, Angers at 1 site in France.
Trial summary
Advances in neurosurgery and neuroresuscitation have improved patients' prognosis. However, 2% of serious head injuries progress to a vegetative state, this condition persisting at 1 year for 1% of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Consciousness Disorder
- What is being tested?
- autobiographic movie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2022to 13 Mar 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed with minimal consciousness
- Patient affiliated or beneficiary of a social security scheme
- Signature of consent by a relative of the patient
- Tolerance of the multisensory stimulation material during the pre-inclusion phase
Who cannot join
- Minor
- Pregnant woman
- Patient with contraindication to study procedures (Contraindication to wearing a virtual reality headset (unbalanced epilepsy, craniofacial trauma, major visual disturbances; contraindication to the fMRI)
- Person deprived of liberty by judicial or administrative decision
- Person receiving psychiatric care under duress
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Angers
Angers
Jean-Michel LEMEE, 0241353637 ext. +33, jmlemee@chu-angers.fr
About this study
Advances in neurosurgery and neuroresuscitation have improved patients' prognosis. However, 2% of serious head injuries progress to a vegetative state, this condition persisting at 1 year for 1% of these patients.
The minimum state of consciousness is to be distinguished from coma and vegetative state, it is a condition marked by a severe alteration of consciousness in which there are minimal and fluctuating, but obvious, signs of environmental consciousness. There is a minimum degree of response to some stimulations, response generally fluctuating over time. In practice, these patients are unable to consistently follow simple instructions, but they often have a preserved visual pursuit (proper rotation of the head when someone enters the room, prolonged eye follow-up, etc.). Patients with minimal awareness have been shown to perceive emotions and pain. These patients may exhibit behavioural and emotional changes (smiling, crying motivated), induced by verbal stimulations (familiar voice). But these events remain fluctuating during the day or according to the days and interlocutors.
Read more
For the moment, the most commonly accepted strategy since the 1990s remains sensory stimulation (SS), while knowing that this term includes extremely varied stimulations (sensory, olfactory, auditory, fixation on a mirror, etc.) without the practice of this technique being well defined and systematized.
It has been shown that a regular family visit program with auditory, emotional and tactile stimuli improves the state of consciousness of these patients. Physicians also know that this SS must be personalized and adapted to the patient's tolerance and premorbid preferences.
SS programmes are poorly standardized. Programmes generally consist of a simple, moderate to high intensity, non-standardized stimulation, presented repetitively and frequently. Indeed, it has been shown that stimulation must begin early, be frequent, and continue until reactions appear.
In this project, investigator want to use the new technologies now commonly used such as photos, videos or sounds taken by smartphone's relatives of the brain patient-injured in order to make a personalized 3D film using film editing software and a predefined film frame, by integrating autobiographical elements and emotional, multisensory (binaural sound, vibration) integrating, if possible, a certain interactivity (haptic feedback, triggering of videos by the patient's eyes).
The objective is to develop an innovative multi-sensory stimulation technique through a personalised enriched environment to induce, facilitate and accelerate the return to consciousness of patients in altered state of consciousness during their initial management.
- Conditions
- Consciousness Disorder
- Being tested
- autobiographic movie
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autobiographic movieOther
viewing an autobiographic film through a virtual reality headset
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality headset | Experimental | Not described Receives: Other: autobiographic movie |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients without any adverse event or sign of bad tolerance
to assess the feasibility of multisensory virtual reality stimulation proposed in this study in patients with minimal post-traumatic consciousness
Measured: 1 month
Secondary outcomes (8)
Time required for film design
to assess the feasibility of making a personalized film
Measured: 2 weeks
type and quantity of autobiographical material to be obtained from the patient's relatives
to assess the feasibility of making a personalized film
Measured: 2 weeks
Patient clinical responses (blood pressure, body motion, eye-tracking)
To assess signs of patient's interaction with the virtual reality headset during the pre-inclusion phase and during the test phase, and the evolution over time of these signs during the test phase
Measured: 1 month
Wessex Head Injury Matrix (WHIM)
To assess the evolution of the patient's clinical status Scale from 0 which means vegetative state to 62 which means pauci-relational state
Measured: 6 month
Coma Recovery Scale - Revised (CRS-R)
To assess the evolution of the patient's clinical status
Measured: 6 month
functional MRI
To assess and compare the different brain networks identified during the fMRI performed one week after the initial fMRI test phase performed the week preceding the test phase.
Measured: 1 month
patient's relative satisfaction scale
To assess patient's family's feelings and experiences with this intervention (interviews etc).
Scale from 1 (minimum) to 7 (maximum); 1 means not satisfied at all and 7 means very satisfied
Measured: 1 month
healthcare team satisfaction scale
To assess healthcare team feelings and experiences with this intervention (adherence to this rehabilitation technique etc) Scale from 1 (minimum) to 7 (maximum); 1 means not satisfied at all and 7 means very satisfied
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start14 Nov 2022
- Primary completion13 Nov 2025 (estimated)
- Study completion13 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consciousness DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978857
- Sponsor's protocol ID
- 49RC20_0238
- Acronym
- REVEIL
- Status last verified
- Jun 2024
- First submitted
- 23 Jul 2021
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Virtual Reality to Promote the Awakening of Patients in a State of Minimal Consciousness
- ClinicalTrials.gov ID
- NCT04978857
- Acronym / sponsor ID
- REVEIL / 49RC20_0238
- Conditions
- Consciousness Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 13 Nov 2025 (estimated)
- Study completion
- 13 Mar 2026 (estimated)
- First posted
- 27 Jul 2021 (actual)
- 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.
Advances in neurosurgery and neuroresuscitation have improved patients' prognosis. However, 2% of serious head injuries progress to a vegetative state, this condition persisting at 1 year for 1% of these patients.
The minimum state of consciousness is to be distinguished from coma and vegetative state, it is a condition marked by a severe alteration of consciousness in which there are minimal and fluctuating, but obvious, signs of environmental consciousness. There is a minimum degree of response to some stimulations, response generally fluctuating over time. In practice, these patients are unable to consistently follow simple instructions, but they often have a preserved visual pursuit (proper rotation of the head when someone enters the room, prolonged eye follow-up, etc.). Patients with minimal awareness have been shown to perceive emotions and pain. These patients may exhibit behavioural and emotional changes (smiling, crying motivated), induced by verbal stimulations (familiar voice). But these events remain fluctuating during the day or according to the days and interlocutors.
For the moment, the most commonly accepted strategy since the 1990s remains sensory stimulation (SS), while knowing that this term includes extremely varied stimulations (sensory, olfactory, auditory, fixation on a mirror, etc.) without the practice of this technique being well defined and systematized.
It has been shown that a regular family visit program with auditory, emotional and tactile stimuli improves the state of consciousness of these patients. Physicians also know that this SS must be personalized and adapted to the patient's tolerance and premorbid preferences.
SS programmes are poorly standardized. Programmes generally consist of a simple, moderate to high intensity, non-standardized stimulation, presented repetitively and frequently. Indeed, it has been shown that stimulation must begin early, be frequent, and continue until reactions appear.
In this project, investigator want to use the new technologies now commonly used such as photos, videos or sounds taken by smartphone's relatives of the brain patient-injured in order to make a personalized 3D film using film editing software and a predefined film frame, by integrating autobiographical elements and emotional, multisensory (binaural sound, vibration) integrating, if possible, a certain interactivity (haptic feedback, triggering of videos by the patient's eyes).
The objective is to develop an innovative multi-sensory stimulation technique through a personalised enriched environment to induce, facilitate and accelerate the return to consciousness of patients in altered state of consciousness during their initial management.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality headset | Experimental | Other: autobiographic movie |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient diagnosed with minimal consciousness
- Patient affiliated or beneficiary of a social security scheme
- Signature of consent by a relative of the patient
- Tolerance of the multisensory stimulation material during the pre-inclusion phase
Key exclusion criteria (5 listed)
- Minor
- Pregnant woman
- Patient with contraindication to study procedures (Contraindication to wearing a virtual reality headset (unbalanced epilepsy, craniofacial trauma, major visual disturbances; contraindication to the fMRI)
- Person deprived of liberty by judicial or administrative decision
- Person receiving psychiatric care under duress
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 |
|---|---|---|
| autobiographic movieviewing an autobiographic film through a virtual reality headset | Other | Virtual reality headset |
Primary outcome
percentage of patients without any adverse event or sign of bad tolerance
Time frame: 1 month
to assess the feasibility of multisensory virtual reality stimulation proposed in this study in patients with minimal post-traumatic consciousness
8 secondary outcomes
Time required for film design
Time frame: 2 weeks
type and quantity of autobiographical material to be obtained from the patient's relatives
Time frame: 2 weeks
Patient clinical responses (blood pressure, body motion, eye-tracking)
Time frame: 1 month
Wessex Head Injury Matrix (WHIM)
Time frame: 6 month
Coma Recovery Scale - Revised (CRS-R)
Time frame: 6 month
functional MRI
Time frame: 1 month
patient's relative satisfaction scale
Time frame: 1 month
healthcare team satisfaction scale
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autobiographic movie in people with Consciousness Disorder, run by University Hospital, Angers at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Michel LEMEE (0241353637 ext. +33, JMLemee@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients without any adverse event or sign of bad tolerance (time frame: 1 month). 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 11 Jun 2024.