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

University Hospital, Angers

Status

Enrolling

Conditions

Consciousness Disorder

Treatments

Other: autobiographic movie

Study type

Interventional

Funder types

Other

Identifiers

NCT04978857

49RC20_0238

Details and patient eligibility

About

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.

Enrollment

8 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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