AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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)
Show all 13Show fewer
  • 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
  • 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

    Recruiting

Other trials in France

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.

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 groups in NCT06719063
Study groupRoleWhat they receive
ExperimentalExperimentalThe 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted5 Dec 2024
  2. Study start4 Apr 2025
  3. Primary completion15 Jun 2025 (estimated)
  4. Study completion31 Aug 2025 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in