StrokeNEGLISENSNCT06719063
Effect of Immersive Virtual Reality With Multisensory Stimulation on the Functional Impact of Hemineglect Secondary to a Right-Sided Stroke
A study testing Multisensory Virtual Reality in people with Stroke and Hemineglect, run by Hopital La Musse at 1 site in France.
Trial summary
A stroke is a common and potentially serious condition that affects 130,000 people each year in France. It is the second leading cause of major cognitive disorders after Alzheimer's disease. Hemineglect is a frequently observed cognitive impairment following a stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemineglect, Neuropsychology
- What is being tested?
- Multisensory Virtual Reality
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2025to 31 Aug 2025
- 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
- Patient aged over 18 years
- Diagnosis of first ischemic right stroke established by a neurologist using clinical examination and brain imaging (CT scan or MRI)
- Stroke occurring less than 3 months ago
- Presence of left hemineglect, diagnosed using the Neglect Assessment Battery (NAB)
- Normal vision or corrected to normal
- Patient affiliated with the social security system
Who cannot join
- History of neurological or psychiatric illness
- Epilepsy
- Craniotomy
- Limited range of cervical motion due to orthopedic disorders
- Moderate or severe deafness (hearing loss of 40 dB in one ear, as measured by tonal audiometry)
- Anosmia (loss of smell)
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- Asthmatic disease
- Pregnant women or women suspected of being pregnant
- Breastfeeding women
- Severe neurocognitive disorders with an MMSE score < 21
- Patient under legal protection measures
- Minor patient
- Patient enrolled in another research protocol
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
Hôpital La Musse
Saint-Sébastien-de-Morsent, 27180
Héloïse BAILLET, PhD, +33(0)232293047, h.baillet@hlrs-lamusse.net
Julie LE BALC'H, +33(0)232293001, j.lebalch@hlrs-lamusse.net
About this study
Official title: Effect of Immersive Virtual Reality With Multisensory Stimulation on the Functional Impact of Hemineglect Secondary to a Right-Sided Stroke: A Single Case Experimental Design (SCED) Study
A stroke is a common and potentially serious condition that affects 130,000 people each year in France. It is the second leading cause of major cognitive disorders after Alzheimer's disease.
Hemineglect is a frequently observed cognitive impairment following a stroke. The individual becomes unable to orient themselves or respond to stimuli appearing in the contralesional hemispace. Hemineglect occurs in approximately 25-30% of stroke patients, with the right hemisphere being affected in 90% of cases.
Read more
Despite potential spontaneous recovery within the first 2 to 3 months post-stroke, neglect tends to persist chronically. One-third of patients suffer from long-term neglect. The condition is more severe after a right-sided lesion. The functional impact is significant, particularly when considering the anosognosia and anosodiaphoria often associated with it. Rehabilitation stays are longer for patients with neglect, and autonomy in daily activities is reduced. Neglect leads to poorer functional outcomes after a stroke, making it a critical factor to address in a patient's rehabilitation program.
The goal of rehabilitation is to reduce impairments, improve activity limitations and participation restrictions secondary to hemineglect, and achieve functional progress beyond what is possible through spontaneous recovery. Since no single rehabilitation method for neglect is superior to another, it is currently recommended to combine multiple approaches.
The top-down approach is based on intention and conscious effort. This technique is among the first used for neglect rehabilitation and remains widely used today. The goal is to help the patient become aware of their neglectful behavior.
The bottom-up approach relies on more automatic mechanisms of action and aims to modulate the spatial reference system through passive sensory manipulations or visuomotor adaptation.
The use of virtual reality in stroke rehabilitation promotes plasticity and neural reorganization. In the field of hemineglect, several studies have examined the effects of virtual reality using top-down and/or bottom-up approaches and have shown significant functional improvements. In the case of multisensory stimulation, delivering different stimuli to the same side of space and at the same time increases neuronal activity, leading to a stronger clinical response than unisensory stimulation.
The VirtySens® multisensory travel capsule is an immersive virtual reality technique. This total immersion is achieved through the simultaneous stimulation of four out of the five senses. Firstly, vision and hearing are stimulated by a virtual reality headset that projects high-definition films. Smell is activated through the release of micro-droplets of fragrances synchronized with the imagery. Finally, touch is stimulated by warm and cold airflows that enhance the various scenes presented.
The investigators emit the hypothesis that the VirtySens® capsule, immersive virtual reality combining multisensory stimulation via four of the five senses and training in visual scanning, introduced in rehabilitation, allows to significantly reduce the functional impact of hemineglect in the adult victim of a right cerebral infarction dating less than 3 months.
To respond to these research objectives, the investigators will carry out a pilot study in Single Case Experimental Design (SCED). The experimentation will take place in mainland France within La Musse hospital. The recruitment of 3 subjects will be necessary for the realization of this study.
The study will consist of repeated evaluation and rehabilitation sessions. Evaluations will be conducted at La Musse Hospital by an occupational therapist. The purpose of the evaluation sessions is to measure the impact of hemineglect on autonomy. This measurement will be performed using the Catherine Bergego Scale, which will be completed by both the patient and the occupational therapist. Evaluation sessions will last approximately 45 minutes and will take place once a week for 10 to 12 weeks.
After 3 to 5 weeks of evaluations, the patient will participate in three weekly rehabilitation sessions, each lasting 45 minutes, over a 5-week period. These sessions will be individual and conducted by an occupational therapist. Each session will follow a similar structure: review of the previous session, explanation of the current session, a 15-minute multisensory experience using virtual reality, followed by a review of the session, particularly focusing on tolerance.
- Conditions
- Stroke, Hemineglect, Neuropsychology, Virtual Reality, Rehabilitation, Immersion
- Being tested
- Multisensory Virtual Reality
- Keywords
- stroke, hemineglect, neuropsychology, virtual reality, rehabilitation, multisensory, immersion
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory Virtual RealityOther
The VirtySens® multisensory travel capsule is an immersive virtual reality technique. This total immersion occurs through the simultaneous stimulation of four of the five senses.
Session duration: 45 minutes, with 15 minutes dedicated to the protocol administration. The remaining 30 minutes will be used to welcome the patient, explain the content of the session, and review the session's outcome, particularly to assess tolerance (Simulator Sickness Questionnaire (SSQ) completed at the start of each week after the first VirtySens® session). The sessions will take place in the morning to prevent the session from being disrupted by fatigue related to the rehabilitation day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The evaluation sessions aim to measure the impact of hemineglect on autonomy. This measurement will be conducted using the Catherine Bergego Scale, which will be completed by both the patient and the occupational therapist. Evaluation sessions will last approximately 45 minutes and will take place once a week for 10 to 12 weeks.
After 3 to 5 weeks of evaluations (Phase A: baseline), the patient will participate in three weekly rehabilitation sessions, each lasting 45 minutes, over a 5-week period (Phase B: therapy). These sessions will be individual and conducted by an occupational therapist. Each session will follow a similar structure: review of the previous session, explanation of the current session, a 15-minute multisensory experience using virtual reality, and a final review focusing particularly on tolerance.
A multisensory experience has been specifically designed for the rehabilitation protocol. The experience consists of two 360° nature-themed films. Throughout the experie Receives: Other: Multisensory Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of hemineglect on autonomy
The evaluation sessions aim to measure the impact of hemineglect on autonomy. This measurement will be conducted using the Catherine Bergego Scale, which will be completed by both the patient and the occupational therapist. This scale is scored from 0 to 30 points; the higher the score, the more severe the behavioural neglect.
Measured: From study enrollment, up to 12 weeks, every 7 days
Secondary outcomes (2)
The measurement of anosognosia or awareness of hemineglect
The measurement of anosognosia or awareness of hemineglect in an ecological setting, using the Catherine Bergego Scale. This scale is scored from 0 to 30 points; the higher the score, the more severe the behavioural neglect.
Measured: From study enrollment, up to 12 weeks, every 7 days
The measurement of tolerance to immersive virtual reality
The measurement of tolerance to immersive virtual reality, combining multisensory stimulation through four of the five senses and visual scanning training, introduced in rehabilitation, using the Simulator Sickness Questionnaire.
This scale is scored from 0 to 48 points, the higher the score, the greater the cybermalaise.
Measured: From study enrollment, up to 12 weeks, every 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start4 Apr 2025
- Primary completion15 Jun 2025 (estimated)
- Study completion31 Aug 2025 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital La Musse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719063
- Sponsor's protocol ID
- 2024-A01439-38
- Acronym
- NEGLISENS
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immersive Virtual Reality With Multisensory Stimulation on the Functional Impact of Hemineglect Secondary to a Right-Sided Stroke: A Single Case Experimental Design (SCED) Study
- ClinicalTrials.gov ID
- NCT06719063
- Acronym / sponsor ID
- NEGLISENS / 2024-A01439-38
- Conditions
- Stroke, Hemineglect, Neuropsychology, Virtual Reality, Rehabilitation, Immersion
- Keywords
- stroke, hemineglect, neuropsychology, virtual reality, rehabilitation, multisensory, immersion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Hopital La MusseUniversity, hospital or other
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 5 Dec 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.
A stroke is a common and potentially serious condition that affects 130,000 people each year in France. It is the second leading cause of major cognitive disorders after Alzheimer's disease.
Hemineglect is a frequently observed cognitive impairment following a stroke. The individual becomes unable to orient themselves or respond to stimuli appearing in the contralesional hemispace. Hemineglect occurs in approximately 25-30% of stroke patients, with the right hemisphere being affected in 90% of cases.
Despite potential spontaneous recovery within the first 2 to 3 months post-stroke, neglect tends to persist chronically. One-third of patients suffer from long-term neglect. The condition is more severe after a right-sided lesion. The functional impact is significant, particularly when considering the anosognosia and anosodiaphoria often associated with it. Rehabilitation stays are longer for patients with neglect, and autonomy in daily activities is reduced. Neglect leads to poorer functional outcomes after a stroke, making it a critical factor to address in a patient's rehabilitation program.
The goal of rehabilitation is to reduce impairments, improve activity limitations and participation restrictions secondary to hemineglect, and achieve functional progress beyond what is possible through spontaneous recovery. Since no single rehabilitation method for neglect is superior to another, it is currently recommended to combine multiple approaches.
The top-down approach is based on intention and conscious effort. This technique is among the first used for neglect rehabilitation and remains widely used today. The goal is to help the patient become aware of their neglectful behavior.
The bottom-up approach relies on more automatic mechanisms of action and aims to modulate the spatial reference system through passive sensory manipulations or visuomotor adaptation.
The use of virtual reality in stroke rehabilitation promotes plasticity and neural reorganization. In the field of hemineglect, several studies have examined the effects of virtual reality using top-down and/or bottom-up approaches and have shown significant functional improvements. In the case of multisensory stimulation, delivering different stimuli to the same side of space and at the same time increases neuronal activity, leading to a stronger clinical response than unisensory stimulation.
The VirtySens® multisensory travel capsule is an immersive virtual reality technique. This total immersion is achieved through the simultaneous stimulation of four out of the five senses. Firstly, vision and hearing are stimulated by a virtual reality headset that projects high-definition films. Smell is activated through the release of micro-droplets of fragrances synchronized with the imagery. Finally, touch is stimulated by warm and cold airflows that enhance the various scenes presented.
The investigators emit the hypothesis that the VirtySens® capsule, immersive virtual reality combining multisensory stimulation via four of the five senses and training in visual scanning, introduced in rehabilitation, allows to significantly reduce the functional impact of hemineglect in the adult victim of a right cerebral infarction dating less than 3 months.
To respond to these research objectives, the investigators will carry out a pilot study in Single Case Experimental Design (SCED). The experimentation will take place in mainland France within La Musse hospital. The recruitment of 3 subjects will be necessary for the realization of this study.
The study will consist of repeated evaluation and rehabilitation sessions. Evaluations will be conducted at La Musse Hospital by an occupational therapist. The purpose of the evaluation sessions is to measure the impact of hemineglect on autonomy. This measurement will be performed using the Catherine Bergego Scale, which will be completed by both the patient and the occupational therapist. Evaluation sessions will last approximately 45 minutes and will take place once a week for 10 to 12 weeks.
After 3 to 5 weeks of evaluations, the patient will participate in three weekly rehabilitation sessions, each lasting 45 minutes, over a 5-week period. These sessions will be individual and conducted by an occupational therapist. Each session will follow a similar structure: review of the previous session, explanation of the current session, a 15-minute multisensory experience using virtual reality, followed by a review of the session, particularly focusing on tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Multisensory Virtual RealityThe evaluation sessions aim to measure the impact of hemineglect on autonomy. This measurement will be conducted using the Catherine Bergego Scale, which will be completed by both the patient and the occupational therapist. Evaluation sessions will last approximately 45 minutes and will take place once a week for 10 to 12 weeks. After 3 to 5 weeks of evaluations (Phase A: baseline), the patient will participate in three weekly rehabilitation sessions, each lasting 45 minutes, over a 5-week period (Phase B: therapy). These sessions will be individual and conducted by an occupational therapist. Each session will follow a similar structure: review of the previous session, explanation of the current session, a 15-minute multisensory experience using virtual reality, and a final review focusing particularly on tolerance. A multisensory experience has been specifically designed for the rehabilitation protocol. The experience consists of two 360° nature-themed films. Throughout the experie |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged over 18 years
- Diagnosis of first ischemic right stroke established by a neurologist using clinical examination and brain imaging (CT scan or MRI)
- Stroke occurring less than 3 months ago
- Presence of left hemineglect, diagnosed using the Neglect Assessment Battery (NAB)
- Normal vision or corrected to normal
Key exclusion criteria (13 listed)
- History of neurological or psychiatric illness
- Epilepsy
- Craniotomy
- Limited range of cervical motion due to orthopedic disorders
- Moderate or severe deafness (hearing loss of 40 dB in one ear, as measured by tonal audiometry)
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 |
|---|---|---|
| Multisensory Virtual RealityThe VirtySens® multisensory travel capsule is an immersive virtual reality technique. This total immersion occurs through the simultaneous stimulation of four of the five senses. Session duration: 45 minutes, with 15 minutes dedicated to the protocol administration. The remaining 30 minutes will be used to welcome the patient, explain the content of the session, and review the session's outcome, particularly to assess tolerance (Simulator Sickness Questionnaire (SSQ) completed at the start of each week after the first VirtySens® session). The sessions will take place in the morning to prevent the session from being disrupted by fatigue related to the rehabilitation day. | Other | Experimental |
Primary outcome
The impact of hemineglect on autonomy
Time frame: From study enrollment, up to 12 weeks, every 7 days
The evaluation sessions aim to measure the impact of hemineglect on autonomy. This measurement will be conducted using the Catherine Bergego Scale, which will be completed by both the patient and the occupational therapist. This scale is scored from 0 to 30 points; the higher the score, the more severe the behavioural neglect.
2 secondary outcomes
The measurement of anosognosia or awareness of hemineglect
Time frame: From study enrollment, up to 12 weeks, every 7 days
The measurement of tolerance to immersive virtual reality
Time frame: From study enrollment, up to 12 weeks, every 7 days
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 11 May 2025.
- Individual participant dataSharing planned: Undecided
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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 Multisensory Virtual Reality in people with Stroke and Hemineglect, run by Hopital La Musse 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 6 inclusion and 13 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 11 May 2025. 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 Héloïse BAILLET, PhD (+33(0)232293047, h.baillet@hlrs-lamusse.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of hemineglect on autonomy (time frame: From study enrollment, up to 12 weeks, every 7 days). 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 11 May 2025.