StrokeNCT06366360
Immersive Virtual Reality Treatment for Unilateral Spatial Neglect
A study testing Immersive Virtual Reality Intervention and Conventional rehabilitation in people with Stroke and Unilateral Spatial Neglect, run by Hopitaux de Saint-Maurice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Unilateral Spatial Neglect
- What is being tested?
- Immersive Virtual Reality Intervention and Conventional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux de Saint-Maurice
Saint-Maurice, 94410
Secretary, 01 43 96 68 22 ext. +33, secretariat.ssrneuro@ght94n.fr
About this study
Official title: Rehabilitation of Unilateral Spatial Neglect Using an Immersive Virtual Reality Music Practice Program
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.
- Conditions
- Stroke, Unilateral Spatial Neglect
- Being tested
- Immersive Virtual Reality Intervention, Conventional rehabilitation
- Keywords
- Rehabilitation, Unilateral Spatial Neglect, Immersive Virtual Reality, Music
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality InterventionOther
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 rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Immersive virtual reality rehabilitation first | Active comparator | 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) Receives: Other: Immersive Virtual Reality Intervention; Other: Conventional rehabilitation |
| Conventional rehabilitation first | Active comparator | 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) Receives: Other: Immersive Virtual Reality Intervention; Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Scene description Task
The patient has to describe the objects in a visual scene presented on an A3 sheet of paper and placed in front of him or her.
The number of omissions in each part of the picture is analyzed. The total score is between 0 and 3: 0 corresponds to 3 or more omissions, 1 to 2 omissions, 2 to 1 omission, and 3 to no omissions. The patient is considered to be deficient if the score exceeds 0.
Measured: 8 weeks
Ecological scale of daily life activities
The patient and a therapist or family member complete a scale that asks questions about everyday activities.
The patient must answer 10 questions, each of which is scored from 0 to 3 according to the severity criterion. 0 corresponds to no neglect and 3 to significant neglect, so the minimum score is 0 and the maximum is 30. If a patient receives a score equal to or greater than 1, he is considered neglected.
Measured: 8 weeks
Piano bisection Task
The patient must indicate which key corresponds to the middle key of the piano. It's a qualitative measure. There are no minimum or maximum values among the 61 piano keys. However, the investigators can consider the minimum to be the actual center key of the piano and the maximum to be the contralesional key of the piano.
Measured: 8 weeks
Identifying the keys at the ends of the piano
The patient must indicate which keys are furthest to the left and right of the piano.
It's a qualitative measure. The maximum value can be considered as the touch at the contralesional end, and the minimum as the touch at the ipsilesional end.
Measured: 8 weeks
Virtual reality Bells Test
The patient is asked to perform the same task as in the classical test, but this time the bells are placed in a virtual environment 120° around the patient.
As in the classical version, the number of total and lateralized omissions is assessed. 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).
Measured: 8 weeks
Auditory Stimuli Localization Task in virtual reality
The patient must localize auditory stimuli in a 180° horizontal virtual environment to a precise point in the virtual environment.
The difference between the real position of the sound and the position targeted by the patient is examined. The minimum value corresponds to no difference and the maximum value corresponds to a maximum difference between these two coordinates.
Measured: 8 weeks
Ecological virtual reality bisection task
The patient has to cut bread sticks of different size into 2 equal parts. The minimum value corresponds to a bisection at the center of the stimulus and the maximum value corresponds to a bisection at the contralesional end of this stimulus. For each stimulus, a calculation is made between the value reported by the patient and the actual expected value.
Measured: 8 weeks
Virtual reality Baking Tray test
The patient must place 16 pieces of dough evenly on a baking tray. The minimum value corresponds to an equal distribution between the 2 hemispaces of the tray (i.e. 8 pieces of dough on each side) and the maximum value corresponds to the positioning of all pieces in the contralesional hemispace. A difference of more than 2 cubes indicates a deficit.
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start11 Mar 2024
- Primary completion12 Jun 2024
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopitaux de Saint-Maurice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366360
- Sponsor's protocol ID
- Piano-Neglect
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Unilateral Spatial Neglect Using an Immersive Virtual Reality Music Practice Program
- ClinicalTrials.gov ID
- NCT06366360
- Acronym / sponsor ID
- Piano-Neglect
- Conditions
- Stroke, Unilateral Spatial Neglect
- Keywords
- Rehabilitation, Unilateral Spatial Neglect, Immersive Virtual Reality, Music
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hopitaux de Saint-MauriceUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immersive virtual reality rehabilitation first | Active comparator | Other: Immersive Virtual Reality Intervention, Other: Conventional rehabilitationEach 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) |
| Conventional rehabilitation first | Active comparator | Other: Immersive Virtual Reality Intervention, Other: Conventional rehabilitationEach 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Epilepsy or migraine
- Major vision problems
- Major hearing impairment
- Pre-existing cognitive impairment (MMSE < 20)
- Major disorders of verbal comprehension preventing the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual Reality 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. | Other | Conventional rehabilitation first, Immersive virtual reality rehabilitation first |
| Conventional rehabilitationThe 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. | Other | Conventional rehabilitation first, Immersive virtual reality rehabilitation first |
Primary outcome
Bells Test
Time frame: 8 weeks
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.
Mesulam cancellation Task
Time frame: 8 weeks
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.
Bisection Test
Time frame: 8 weeks
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.
Copying Test
Time frame: 8 weeks
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.
Scene description Task
Time frame: 8 weeks
The patient has to describe the objects in a visual scene presented on an A3 sheet of paper and placed in front of him or her. The number of omissions in each part of the picture is analyzed. The total score is between 0 and 3: 0 corresponds to 3 or more omissions, 1 to 2 omissions, 2 to 1 omission, and 3 to no omissions. The patient is considered to be deficient if the score exceeds 0.
Ecological scale of daily life activities
Time frame: 8 weeks
The patient and a therapist or family member complete a scale that asks questions about everyday activities. The patient must answer 10 questions, each of which is scored from 0 to 3 according to the severity criterion. 0 corresponds to no neglect and 3 to significant neglect, so the minimum score is 0 and the maximum is 30. If a patient receives a score equal to or greater than 1, he is considered neglected.
Piano bisection Task
Time frame: 8 weeks
The patient must indicate which key corresponds to the middle key of the piano. It's a qualitative measure. There are no minimum or maximum values among the 61 piano keys. However, the investigators can consider the minimum to be the actual center key of the piano and the maximum to be the contralesional key of the piano.
Identifying the keys at the ends of the piano
Time frame: 8 weeks
The patient must indicate which keys are furthest to the left and right of the piano. It's a qualitative measure. The maximum value can be considered as the touch at the contralesional end, and the minimum as the touch at the ipsilesional end.
Virtual reality Bells Test
Time frame: 8 weeks
The patient is asked to perform the same task as in the classical test, but this time the bells are placed in a virtual environment 120° around the patient. As in the classical version, the number of total and lateralized omissions is assessed. 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).
Auditory Stimuli Localization Task in virtual reality
Time frame: 8 weeks
The patient must localize auditory stimuli in a 180° horizontal virtual environment to a precise point in the virtual environment. The difference between the real position of the sound and the position targeted by the patient is examined. The minimum value corresponds to no difference and the maximum value corresponds to a maximum difference between these two coordinates.
Ecological virtual reality bisection task
Time frame: 8 weeks
The patient has to cut bread sticks of different size into 2 equal parts. The minimum value corresponds to a bisection at the center of the stimulus and the maximum value corresponds to a bisection at the contralesional end of this stimulus. For each stimulus, a calculation is made between the value reported by the patient and the actual expected value.
Virtual reality Baking Tray test
Time frame: 8 weeks
The patient must place 16 pieces of dough evenly on a baking tray. The minimum value corresponds to an equal distribution between the 2 hemispaces of the tray (i.e. 8 pieces of dough on each side) and the maximum value corresponds to the positioning of all pieces in the contralesional hemispace. A difference of more than 2 cubes indicates a deficit.
2 secondary outcomes
Mood assessment
Time frame: 4 weeks
Situational motivation questionnaire
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality Intervention and Conventional rehabilitation in people with Stroke and Unilateral Spatial Neglect, run by Hopitaux de Saint-Maurice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Auriane AS SLAMA, ARC (06 07 31 79 69 ext. +33, auriane.slama@hpevm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bells Test (time frame: 8 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.