Spatial NeglectCogSpa-VRNCT05723146
Spatial Cognition Assessment in Virtual Reality
A study testing Spatial cognition assessment in people with Spatial Neglect, run by Université Paris Cité at 1 site in France.
Trial summary
Unilateral spatial neglect (USN) is a highly-prevalent neuropsychological syndrome following a cerebral stroke characterized by massive impairments in daily life. The evaluation and the rehabilitation of USN encounter many limits whereas immersive virtual reality (VR) could be an efficient tool to go through these… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spatial Neglect
- What is being tested?
- Spatial cognition assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral right stroke
Who cannot join
- epilepsy / migraine
- craniotomy
- major sensory/motor deficit
- severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Unilateral spatial neglect (USN) is a highly-prevalent neuropsychological syndrome following a cerebral stroke characterized by massive impairments in daily life. The evaluation and the rehabilitation of USN encounter many limits whereas immersive virtual reality (VR) could be an efficient tool to go through these limits by imitating an environment of perception and action very close to the real one. The investigators will test a multisensory battery of evaluation based on VR for the diagnostic of USN.
- Conditions
- Spatial Neglect
- Being tested
- Spatial cognition assessment
- Keywords
- spatial neglect, virtual reality, assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial cognition assessmentBehavioural
The intervention will be composed of tasks assessing spatial cognition in a real environment (cancellation task, line bisection and baking tray task) and in a virtual environment (cancellation task, line bisection, baking tray task and localization tasks).The Catherine Bergego Scale (questionnaire) will also be used.
| Study group | Role | What they receive |
|---|---|---|
| Spatial cognition assessment | Experimental | A single session of spatial cognition assessment (baseline) will be proposed to participants. This assessment will be based on paper-and-pencil tasks and immersive virtual reality tasks (with an HTC Vive Pro Head-Mounted-Display). The assessment will last around 1 hour. Receives: Behavioral: Spatial cognition assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omissions in cancellation tasks
Number and localization in space
Measured: Baseline
Deviation in line bisection tasks
Deviation of the bisection from the true center of the lines (in mm)
Measured: Baseline
Number of the cubes in each side of space in the Baking Tray Tasks
16 cubes have to be disposed
Measured: Baseline
Detections in the localization tasks
Number and localization in space
Measured: Baseline
Secondary outcomes (3)
Duration of eye fixation in each side of space during VR tasks
Collected thanks to the VR headset
Measured: Baseline
Completion time of each task
(in s)
Measured: Baseline
Score in the Catherine Bergego Scale (CBS)
Functional assessment scored by the occupational therapists. Minimum: 0 / Maximum: 30 / Higher scores mean a better outcome
Measured: Assessed within the same week as Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spatial NeglectStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 60 patients with right stroke will be included in this study: a group of 30 patients with USN will be compared to a group of 30 patients without USN.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Paris Cité
- Sponsor type
- University, hospital or other
- Collaborators
- Hopitaux de Saint-Maurice, Université Paris-Saclay
- Responsible party
- Principal investigator, Alma Guilbert, Université Paris Cité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723146
- Sponsor's protocol ID
- CogSpa-VR
- Acronym
- CogSpa-VR
- Status last verified
- May 2024
- First submitted
- 3 Jan 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Cognition Assessment in Virtual Reality
- ClinicalTrials.gov ID
- NCT05723146
- Acronym / sponsor ID
- CogSpa-VR / CogSpa-VR
- Conditions
- Spatial Neglect
- Keywords
- spatial neglect, virtual reality, assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Université Paris CitéUniversity, hospital or other
- Collaborators
- Hopitaux de Saint-Maurice, Université Paris-Saclay
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Feb 2023 (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 highly-prevalent neuropsychological syndrome following a cerebral stroke characterized by massive impairments in daily life. The evaluation and the rehabilitation of USN encounter many limits whereas immersive virtual reality (VR) could be an efficient tool to go through these limits by imitating an environment of perception and action very close to the real one. The investigators will test a multisensory battery of evaluation based on VR for the diagnostic of USN.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 60 patients with right stroke will be included in this study: a group of 30 patients with USN will be compared to a group of 30 patients without USN.
| Arm | Type | Receives |
|---|---|---|
| Spatial cognition assessment | Experimental | Behavioral: Spatial cognition assessmentA single session of spatial cognition assessment (baseline) will be proposed to participants. This assessment will be based on paper-and-pencil tasks and immersive virtual reality tasks (with an HTC Vive Pro Head-Mounted-Display). The assessment will last around 1 hour. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- unilateral right stroke
Key exclusion criteria (4 listed)
- epilepsy / migraine
- craniotomy
- major sensory/motor deficit
- severe cognitive impairment
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 |
|---|---|---|
| Spatial cognition assessmentThe intervention will be composed of tasks assessing spatial cognition in a real environment (cancellation task, line bisection and baking tray task) and in a virtual environment (cancellation task, line bisection, baking tray task and localization tasks).The Catherine Bergego Scale (questionnaire) will also be used. | Behavioural | Spatial cognition assessment |
Primary outcome
Omissions in cancellation tasks
Time frame: Baseline
Number and localization in space
Deviation in line bisection tasks
Time frame: Baseline
Deviation of the bisection from the true center of the lines (in mm)
Number of the cubes in each side of space in the Baking Tray Tasks
Time frame: Baseline
16 cubes have to be disposed
Detections in the localization tasks
Time frame: Baseline
Number and localization in space
3 secondary outcomes
Duration of eye fixation in each side of space during VR tasks
Time frame: Baseline
Completion time of each task
Time frame: Baseline
Score in the Catherine Bergego Scale (CBS)
Time frame: Assessed within the same week as Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Strategy Training for Optimizing Attention for Individuals With Spatial Neglect
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Prism Adaptation Therapy (PAT) for Right Brain Stroke Rehabilitation
Spatial Neglect After Right Brain Stroke
Not yet recruitingObservational study
Validation of Web-Based Star Cancellation and Line Bisection Tests in Hemiplegic Stroke
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spatial cognition assessment in people with Spatial Neglect, run by Université Paris Cité 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alma Guilbert, PhD (+33176533178, alma.guilbert@u-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Omissions in cancellation tasks (time frame: Baseline). The study lists 4 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 8 May 2024.