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Feasibility Study of Virtual Reality to Promote the Awakening of Patients in a State of Minimal Consciousness (REVEIL)

Primary Purpose

Consciousness Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
autobiographic movie
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Consciousness Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • CHU AngersRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual reality headset

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time required for film design
to assess the feasibility of making a personalized film
type and quantity of autobiographical material to be obtained from the patient's relatives
to assess the feasibility of making a personalized film
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
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
Coma Recovery Scale - Revised (CRS-R)
To assess the evolution of the patient's clinical status
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.
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
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

Full Information

First Posted
July 23, 2021
Last Updated
February 9, 2023
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04978857
Brief Title
Feasibility Study of Virtual Reality to Promote the Awakening of Patients in a State of Minimal Consciousness
Acronym
REVEIL
Official Title
Feasibility Study of Virtual Reality to Promote the Awakening of Patients in a State of Minimal Consciousness
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
November 13, 2025 (Anticipated)
Study Completion Date
November 13, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Consciousness Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality headset
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
autobiographic movie
Intervention Description
viewing an autobiographic film through a virtual reality headset
Primary Outcome Measure Information:
Title
percentage of patients without any adverse event or sign of bad tolerance
Description
to assess the feasibility of multisensory virtual reality stimulation proposed in this study in patients with minimal post-traumatic consciousness
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Time required for film design
Description
to assess the feasibility of making a personalized film
Time Frame
2 weeks
Title
type and quantity of autobiographical material to be obtained from the patient's relatives
Description
to assess the feasibility of making a personalized film
Time Frame
2 weeks
Title
Patient clinical responses (blood pressure, body motion, eye-tracking)
Description
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
Time Frame
1 month
Title
Wessex Head Injury Matrix (WHIM)
Description
To assess the evolution of the patient's clinical status Scale from 0 which means vegetative state to 62 which means pauci-relational state
Time Frame
6 month
Title
Coma Recovery Scale - Revised (CRS-R)
Description
To assess the evolution of the patient's clinical status
Time Frame
6 month
Title
functional MRI
Description
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.
Time Frame
1 month
Title
patient's relative satisfaction scale
Description
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
Time Frame
1 month
Title
healthcare team satisfaction scale
Description
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
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Michel LEMEE
Phone
0241353637
Ext
+33
Email
JMLemee@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
DRCI Promotion Interne
Phone
0241353637
Ext
+33
Email
DRCI-Promotion-Interne@chu-angers.fr
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Michel LEMEE
Phone
0241353637
Ext
+33
Email
jmlemee@chu-angers.fr

12. IPD Sharing Statement

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Feasibility Study of Virtual Reality to Promote the Awakening of Patients in a State of Minimal Consciousness

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