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

NCT04978857 | Recruiting

• 1 other identifier: 49RC20_0238
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Consciousness Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Time required for film design

  2 weeks

• type and quantity of autobiographical material to be obtained from the patient's relatives

  2 weeks

• Patient clinical responses (blood pressure, body motion, eye-tracking)

  1 month

• Wessex Head Injury Matrix (WHIM)

  6 month

• Coma Recovery Scale - Revised (CRS-R)

  6 month

Study Arms (1)

Virtual reality headset

EXPERIMENTAL

Other: autobiographic movie

Interventions

autobiographic movie OTHER

viewing an autobiographic film through a virtual reality headset

Virtual reality headset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed with minimal consciousness
• Patient affiliated or beneficiary of a social security scheme
• Signature of consent by a relative of the patient

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, France

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Jean-Michel LEMEE

CONTACT

0241353637; JMLemee@chu-angers.fr

DRCI Promotion Interne

CONTACT

0241353637; DRCI-Promotion-Interne@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: July 27, 2021
• Study Start: November 14, 2022
• Primary Completion: November 13, 2025
• Study Completion: March 13, 2026
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

FR (1)