Immersive Virtual Reality Treatment for Unilateral Spatial Neglect
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHopitaux de Saint-Maurice
About this trial
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
This trial does not accept healthy volunteersQualifiers
Men and women over 18 years
Free and informed written consent
Enrolled in the French social security system
Cerebral lesion of vascular origin
Disqualifiers
Epilepsy or migraine
Major vision problems
Major hearing impairment
Pre-existing cognitive impairment (MMSE < 20)
Trial design
Design model
Crossover
Treatments tested in this trial
Immersive Virtual Reality Intervention
Other interventionThe 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
Other interventionThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Immersive virtual reality rehabilitation firstActive comparator 2 interventions
Group B: Conventional rehabilitation firstActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Bells Test
The patient has to circle 35 bells placed on an A4 sheet between distractors. The number of total and lateralized omissions is examined. The minimum value corresponds to the absence of omissions and the maximum value corresponds to the total number of stimuli (35 bells) or the number of lateralized stimuli (15 bells in each hemifield). Specifically, if the total number of omissions is greater than 6, or the difference in omissions between the two sides of the sheet is greater than 2, the patient is considered deficient.
Time frame
8 weeks2
Mesulam cancellation Task
The patient has to cross out a target stimulus (the letter A) among other distracting letters arranged on a sheet of A4 paper. The number of total and lateralized omissions on each side of the sheet is analyzed. A maximum score of 60 omissions can be recorded. 30 lateralized omissions is possible and a minimum score of 0 lateralized omissions is also possible.
Time frame
8 weeks3
Bisection Test
The patient must cut the lines of different lengths (20 cm and 5 cm) into two equal parts. The minimum value corresponds to a bisection at the center of the stimuli and the maximum value corresponds to a bisection at the contralesional end of this stimulus. More specifically, for the 20 cm lines, a deviation of +6.5 mm or -7.3 mm is considered a deficit, and for the 5 cm lines, a deviation of +2 mm or -2 mm is considered a deficit.
Time frame
8 weeks4
Copying Test
The patient has to copy a figure representing a house with trees on both sides on a sheet of A4 paper. Each element of the drawing is individually marked with a score of 0 (if not represented or poorly represented) or 1 (if well represented). The omission of an element is considered a deficit and corresponds to a score below the maximum of 6.
Time frame
8 weeksSecondary outcomes
1
Mood assessment
At the beginning and end of each session, patients are asked to rate their mood on a visual analog scale from 1 to 10 to quantify the impact of their mood on the treatment.
Time frame
4 weeks2
Situational motivation questionnaire
Before and after each intervention, patients are asked to complete a Situational Motivation Questionnaire to assess the impact of their words on their health.
Time frame
4 weeksSponsors and contacts
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Source ClinicalTrials.gov