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

Consciousness Disorder Clinical Trial

— REVEIL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04978857
• Other study ID #: 49RC20_0238
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: March 13, 2026

Study information

• Verified date: June 2024
• Source: University Hospital, Angers
• Contact: Jean-Michel LEMEE
• Phone: 0241353637
• Email: JMLemee[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: March 13, 2026
• Est. primary completion date: November 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorder
• Consciousness Disorders

Intervention

Other:
• autobiographic movie
viewing an autobiographic film through a virtual reality headset

Locations

Country	Name	City	State
France	CHU Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month
Secondary	Time required for film design	to assess the feasibility of making a personalized film	2 weeks
Secondary	type and quantity of autobiographical material to be obtained from the patient's relatives	to assess the feasibility of making a personalized film	2 weeks
Secondary	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	1 month
Secondary	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	6 month
Secondary	Coma Recovery Scale - Revised (CRS-R)	To assess the evolution of the patient's clinical status	6 month
Secondary	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.	1 month
Secondary	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	1 month
Secondary	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	1 month