Immersive Virtual Reality Treatment for Unilateral Spatial Neglect

NCT ID: NCT06366360

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Unilateral Spatial Neglect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Immersive virtual reality rehabilitation first

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)

Group Type ACTIVE_COMPARATOR

Immersive Virtual Reality Intervention

Intervention Type OTHER

The immersive virtual reality rehabilitation protocol is an experimental protocol based on musical practice. This protocol will be based on the "Piano Vision" application, which allows several modes of music production: free or guided musical practice.

Conventional rehabilitation

Intervention Type OTHER

The conventional rehabilitation corresponds to the classically performed in the cognitive treatment of unilateral spatial neglect. It involves training visual scanning using barrage exercises, sequence identification, scene description, and pointing.

Conventional rehabilitation first

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)

Group Type ACTIVE_COMPARATOR

Immersive Virtual Reality Intervention

Intervention Type OTHER

The immersive virtual reality rehabilitation protocol is an experimental protocol based on musical practice. This protocol will be based on the "Piano Vision" application, which allows several modes of music production: free or guided musical practice.

Conventional rehabilitation

Intervention Type OTHER

The conventional rehabilitation corresponds to the classically performed in the cognitive treatment of unilateral spatial neglect. It involves training visual scanning using barrage exercises, sequence identification, scene description, and pointing.

Interventions

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Immersive Virtual Reality Intervention

The immersive virtual reality rehabilitation protocol is an experimental protocol based on musical practice. This protocol will be based on the "Piano Vision" application, which allows several modes of music production: free or guided musical practice.

Intervention Type OTHER

Conventional rehabilitation

The conventional rehabilitation corresponds to the classically performed in the cognitive treatment of unilateral spatial neglect. It involves training visual scanning using barrage exercises, sequence identification, scene description, and pointing.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopitaux de Saint-Maurice

OTHER

Sponsor Role lead

Responsible Party

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Silvia Silvestri

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hôpitaux de Saint-Maurice

Saint-Maurice, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marine GAFFARD, PhD student

Role: CONTACT

01 43 96 68 22 ext. +33

Clémence BOURLON, PhD

Role: CONTACT

01 43 96 63 08 ext. +33

Facility Contacts

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Secretary

Role: primary

01 43 96 68 22 ext. +33

Other Identifiers

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Piano-Neglect

Identifier Type: -

Identifier Source: org_study_id

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