Clinical trial NCT04978857: Feasibility Study of Virtual Reality to Promote the Awakening of Patients in a State of Minimal Consciousness
Official title: Feasibility Study of Virtual Reality to Promote the Awakening of Patients in a State of Minimal Consciousness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Consciousness Disorder
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-07-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: percentage of patients without any adverse event or sign of bad tolerance
timeFrame: 1 month
Secondary outcomes:
measure: Time required for film design
timeFrame: 2 weeks
measure: type and quantity of autobiographical material to be obtained from the patient's relatives
timeFrame: 2 weeks
measure: Patient clinical responses (blood pressure, body motion, eye-tracking)
timeFrame: 1 month
measure: Wessex Head Injury Matrix (WHIM)
timeFrame: 6 month
measure: Coma Recovery Scale - Revised (CRS-R)
timeFrame: 6 month
measure: functional MRI
timeFrame: 1 month
measure: patient's relative satisfaction scale
timeFrame: 1 month
measure: healthcare team satisfaction scale
timeFrame: 1 month
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
References: