Immersive Virtual Reality Treatment for Unilateral Spatial Neglect

Hopitaux de Saint-Maurice

Status: Enrolling

Conditions: Stroke; Unilateral Spatial Neglect

Treatments: Other: Conventional rehabilitation; Other: Immersive Virtual Reality Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06366360

Piano-Neglect

Details and patient eligibility

About

Unilateral Spatial Neglect (USN) is a relatively common neuropsychological syndrome following stroke. It is characterized by difficulties in detecting, orienting and identifying events located in the hemispace contralateral to a brain lesion, unrelated to a primary motor or sensory disorder. Numerous methods have been developed for the rehabilitation of this syndrome. However, limitations in terms of efficacy are highlighted. These limitations may be linked to the fact that these methods are restricted to certain sensory modalities, thus failing to take into account the heterogeneity of the syndrome. Moreover, some patients' adherence to rehabilitation programs can also be complicated by motivational difficulties. Immersive Virtual Reality could help overcome these limitations. Indeed, it enables the introduction of new sensory modalities, notably auditory, to support a better apprehension of space.

The main objective of this study is to determine the efficacy of an immersive virtual reality rehabilitation protocol based on musical practice in patients suffering from USN. This study also aims to explore the benefits of this rehabilitation protocol on patients' daily lives, as well as to explore the influence of patients' mood and motivation on the benefits of the immersive virtual reality rehabilitation protocol.

To achieve these goals, patients will benefit from immersive virtual reality rehabilitation based on music practice. This rehabilitation will be compared to conventional USN rehabilitation. To this end, patients will be divided into two groups: classical rehabilitation only or classical rehabilitation and immersive virtual reality in parallel. Each patient will be randomly assigned to one of the two groups for a period of 2 weeks. Pre- and post-rehabilitation assessments will be provided.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women over 18 years
• Free and informed written consent
• Enrolled in the French social security system
• Cerebral lesion of vascular origin
• Unilateral spatial neglect syndrome

Exclusion criteria

• Epilepsy or migraine
• Major vision problems
• Major hearing impairment
• Pre-existing cognitive impairment (MMSE < 20)
• Major disorders of verbal comprehension preventing the protocol
• Refusal to sign consent form

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Immersive virtual reality rehabilitation first

Active Comparator group

Description:

Each patient received 2 rehabilitations: both an immersive virtual reality and a conventional rehabilitation first (during 2 weeks), and then conventional rehabilitation alone (during 2 weeks)

Treatment:

Other: Immersive Virtual Reality Intervention

Other: Conventional rehabilitation

Conventional rehabilitation first

Active Comparator group

Description:

Each patient received 2 rehabilitations: a conventional rehabilitation alone first (during 2 weeks), and then both conventional rehabilitation and immersive virtual reality rehabilitation (during 2 weeks)

Treatment:

Other: Immersive Virtual Reality Intervention

Other: Conventional rehabilitation