Clinical trial NCT06366360: Immersive Virtual Reality Treatment for Unilateral Spatial Neglect
Official title: Rehabilitation of Unilateral Spatial Neglect Using an Immersive Virtual Reality Music Practice Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Unilateral Spatial Neglect
Keywords: Rehabilitation
Unilateral Spatial Neglect
Immersive Virtual Reality
Music
Lead sponsor: Hopitaux de Saint-Maurice
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each patient was assigned to a group that received 2 rehabilitations for 4 weeks, 1) both Immersive virtual reality therapy and a conventional rehabilitation first, and then conventional rehabilitation alone, or 2) A conventional rehabilitation alone and then both Immersive virtual reality therapy, and conventional rehabilitation.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Bells Test
timeFrame: 8 weeks
measure: Mesulam cancellation Task
timeFrame: 8 weeks
measure: Bisection Test
timeFrame: 8 weeks
measure: Copying Test
timeFrame: 8 weeks
measure: Scene description Task
timeFrame: 8 weeks
measure: Ecological scale of daily life activities
timeFrame: 8 weeks
measure: Piano bisection Task
timeFrame: 8 weeks
measure: Identifying the keys at the ends of the piano
timeFrame: 8 weeks
measure: Virtual reality Bells Test
timeFrame: 8 weeks
measure: Auditory Stimuli Localization Task in virtual reality
timeFrame: 8 weeks
measure: Ecological virtual reality bisection task
timeFrame: 8 weeks
measure: Virtual reality Baking Tray test
timeFrame: 8 weeks
Secondary outcomes:
measure: Mood assessment
timeFrame: 4 weeks
measure: Situational motivation questionnaire
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Saint-Maurice
country: France
facility: Hôpitaux de Saint-Maurice
Study officials:
References: