Healthy VolunteersPRIS'TUELNCT03807401
A Technical Innovation of Prismatic Adaptation Test in Healthy Subject, in Favour of Autonomy and Independence in Daily Life Following a Brain Injury
A study testing Prismatic goggles and Virtual reality device in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Unilateral neglect is a neuropsychological disorder reflected by a disturbance in the spatial exploration and distribution of directed attention affecting the contralateral part of space and body relatively to the brain lesion. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Prismatic goggles and Virtual reality device
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2019to 8 Apr 2028
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- Right-handed
- Aged 18 to 70
- Normal or corrected vision
- Signed written informed consent
- Affiliated to a health care organism.
Who cannot join
- Neurological or psychiatric disorder
- Cognitive disorders
- presence of corrective eyeglasses
- Right upper limb orthopedic disorders
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
Lyon Neuroscience Research Center
Bron, 69500
Yves ROSSETTI, MD, 04 72 91 34 00 ext. +33, yves.rossetti@inserm.fr
Alessandro FARNE, PhD, 04 72 91 34 12 ext. +33, Alessandro.farne@inserm.fr
About this study
Official title: To Simulate Prismatic Adaptation in Healthy Subject : a Technical Innovation in Favour of Autonomy and Independence in Daily Life Following a Brain Injury
Unilateral neglect is a neuropsychological disorder reflected by a disturbance in the spatial exploration and distribution of directed attention affecting the contralateral part of space and body relatively to the brain lesion. The chronic aspect of this pathology leads to a poor progression following rehabilitation and a decreased independence of patients in daily life. Thus, it is necessary to set up efficient and long lasting therapies for unilateral neglect patients to improve their daily quality of life. Prismatic adaptation is now a classical method which allows patients to improve their neglect through corrective pointing movements in response to a lateral displacement of the visual field. A large and growing body of literature has investigated prismatic adaptation as a very promising rehabilitation method, improving both visuomotor and cognitive features of unilateral neglect. However, its effects are somehow irregular and clinical applications of this method are still limited. The necessity for patients to come to the hospital to take advantage of prismatic adaption sessions draws some limitations about our knowledge concerning 1) the temporal dynamic of prism adaptation effects on a long-term basis and 2) the optimal duration of treatment (most of the time constrained by the hospitalization duration) and its therapeutical effects on a very long-term basis. Moreover, a large number of patients also suffer from motor deficits which reduce the possibility to optimize the prismatic adaptation session.
Thus, the aim of this project is to develop and validate others modalities of prismatic adaptation which can be applied at home and for a longer duration. These modalities should allow the investigator to get insights about the temporal dynamic of prismatic adaptation on the cognitive system. First, the investigator will investigate the effects of a prismatic adaptation modality using virtual reality to reproduce the lateral displacement induced by the prismatic goggles. He will also investigate prismatic adaptation induced by motor imagery, i.e. with mental representations of pointing movements without concomitant motor execution. This project could enhance the fundamental knowledge and enable to design new modalities of therapeutical use of prismatic adaptation (virtual or imaged) so as to allow a home-based treatment and follow-up. Thus, the aim of this project is to demonstrate the implication of similar mechanisms through different modalities (virtual and imaged compared to classical application) and the feasibility of these new modalities of healthy subjects. Thereafter, the aim will be to use knowledge acquired during this project to set up clinical trials to test for the efficiency of these modalities on a long-term basis in a pathological population.
- Conditions
- Healthy Volunteers
- Being tested
- Prismatic goggles, Virtual reality device
- Keywords
- Virtual Reality, prismatic adaptation, motor imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prismatic gogglesBehavioural
Goggles inducing a lateral displacement of the virtual field of ten degrees. Participants will be asked to wear those goggles during adaptation session and to perform pointing movement toward visual target.
Virtual reality deviceBehavioural
The lateral displacement will be simulated thanks to a virtual reality environment. Participants will wear an Oculus Rift instead of the prismatic goggles and will perform pointing movement as well.
Prismatic gogglesBehavioural
Goggles inducing a lateral displacement of the virtual field of ten degrees. Participants will be asked to wear those goggles during adaptation session and to mentally perform pointing movement toward visual target. There will be no concurrent movement execution.
| Study group | Role | What they receive |
|---|---|---|
| Classical prismatic adaptation | Active comparator | Classical prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left) Receives: Behavioral: Prismatic goggles |
| Virtual prismatic adaptation | Experimental | virtual prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left) Receives: Behavioral: Virtual reality device |
| Imaged prismatic adaptation | Experimental | Imaged prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left) Receives: Behavioral: Prismatic goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensorimotor performances : measure of deviations in mm
Task 1 : Line bisection to assess visuo-spatial bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
For the Line bisection test, the reference point is the middle of the line.
Measured: Day 0 - right before adaption
Visuospatial performances : measure of deviations in mm
Task 1 : Line bisection to assess visuo-spatial bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
For the Line bisection test, the reference point is the middle of the line.
Measured: Day 0 - right before adaption
Visuospatial performances : measure of deviations in mm
Task 1 : Line bisection to assess visuo-spatial bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
For the Line bisection test, the reference point is the middle of the line.
Measured: Day 0 - right after adaption
sensorimotor performances : measure of deviations in mm
Task 1 : Line bisection to assess visuo-spatial bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
For the Line bisection test, the reference point is the middle of the line.
Measured: Day 0 - right after adaption
Visuospatial performances : measure of deviations in mm
Task 2 : Goal-directed pointing to assess sensorimotor bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
For the Goal-directed pointing test, the reference point is the target.
Measured: Day 0 - right before adaption
sensorimotor performances : measure of deviations in mm
Task 2 : Goal-directed pointing to assess sensorimotor bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
For the Goal-directed pointing test, the reference point is the target.
Measured: Day 0 - right before adaption
Visuospatial performances : measure of deviations in mm
Task 2 : Goal-directed pointing to assess sensorimotor bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
For the Goal-directed pointing test, the reference point is the target.
Measured: Day 0 - right after adaption
sensorimotor performances : measure of deviations in mm
Task 2 : Goal-directed pointing to assess sensorimotor bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
For the Goal-directed pointing test, the reference point is the target.
Measured: Day 0 - right after adaption
Visuospatial performances : measure of deviations in mm
Task 3 : Straight Ahead pointing to assess proprioceptive bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
For the Straight Ahead pointing and Visual judgement tests, the reference point is a central imaginary line
Measured: Day 0 - right before adaption
sensorimotor performances : measure of deviations in mm
Task 3 : Straight Ahead pointing to assess proprioceptive bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
For the Straight Ahead pointing and Visual judgement tests, the reference point is a central imaginary line
Measured: Day 0 - right before adaption
Visuospatial performances : measure of deviations in mm
Task 3 : Straight Ahead pointing to assess proprioceptive bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
For the Straight Ahead pointing and Visual judgement tests, the reference point is a central imaginary line
Measured: Day 0 - right after adaption
sensorimotor performances : measure of deviations in mm
Task 3 : Straight Ahead pointing to assess proprioceptive bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
For the Straight Ahead pointing and Visual judgement tests, the reference point is a central imaginary line
Measured: Day 0 - right after adaption
Visuospatial performances : measure of deviations in mm
Task 4 : Visual judgement to assess visual bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
Measured: Day 0 - right before adaption
sensorimotor performances : measure of deviations in mm
Task 4 : Visual judgement to assess visual bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
Measured: Day 0 - right before adaption
Visuospatial performances : measure of deviations in mm
Task 4 : Visual judgement to assess visual bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
Measured: Day 0 - right after adaption
sensorimotor performances : measure of deviations in mm
Task 4 : Visual judgement to assess visual bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
Measured: Day 0 - right after adaption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start8 Oct 2019
- Primary completion8 Apr 2028 (estimated)
- Study completion8 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves ROSSETTI, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807401
- Sponsor's protocol ID
- 69HCL18_0721
- Other IDs
- 2018-A03175-50
- Acronym
- PRIS'TUEL
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2018
- Last updated
- 16 Apr 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Simulate Prismatic Adaptation in Healthy Subject : a Technical Innovation in Favour of Autonomy and Independence in Daily Life Following a Brain Injury
- ClinicalTrials.gov ID
- NCT03807401
- Acronym / sponsor ID
- PRIS'TUEL / 69HCL18_0721
- Conditions
- Healthy Volunteers
- Keywords
- Virtual Reality, prismatic adaptation, motor imagery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 8 Apr 2028 (estimated)
- Study completion
- 8 Apr 2028 (estimated)
- First posted
- 16 Jan 2019 (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 neglect is a neuropsychological disorder reflected by a disturbance in the spatial exploration and distribution of directed attention affecting the contralateral part of space and body relatively to the brain lesion. The chronic aspect of this pathology leads to a poor progression following rehabilitation and a decreased independence of patients in daily life. Thus, it is necessary to set up efficient and long lasting therapies for unilateral neglect patients to improve their daily quality of life. Prismatic adaptation is now a classical method which allows patients to improve their neglect through corrective pointing movements in response to a lateral displacement of the visual field. A large and growing body of literature has investigated prismatic adaptation as a very promising rehabilitation method, improving both visuomotor and cognitive features of unilateral neglect. However, its effects are somehow irregular and clinical applications of this method are still limited. The necessity for patients to come to the hospital to take advantage of prismatic adaption sessions draws some limitations about our knowledge concerning 1) the temporal dynamic of prism adaptation effects on a long-term basis and 2) the optimal duration of treatment (most of the time constrained by the hospitalization duration) and its therapeutical effects on a very long-term basis. Moreover, a large number of patients also suffer from motor deficits which reduce the possibility to optimize the prismatic adaptation session.
Thus, the aim of this project is to develop and validate others modalities of prismatic adaptation which can be applied at home and for a longer duration. These modalities should allow the investigator to get insights about the temporal dynamic of prismatic adaptation on the cognitive system. First, the investigator will investigate the effects of a prismatic adaptation modality using virtual reality to reproduce the lateral displacement induced by the prismatic goggles. He will also investigate prismatic adaptation induced by motor imagery, i.e. with mental representations of pointing movements without concomitant motor execution. This project could enhance the fundamental knowledge and enable to design new modalities of therapeutical use of prismatic adaptation (virtual or imaged) so as to allow a home-based treatment and follow-up. Thus, the aim of this project is to demonstrate the implication of similar mechanisms through different modalities (virtual and imaged compared to classical application) and the feasibility of these new modalities of healthy subjects. Thereafter, the aim will be to use knowledge acquired during this project to set up clinical trials to test for the efficiency of these modalities on a long-term basis in a pathological population.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Classical prismatic adaptation | Active comparator | Behavioral: Prismatic gogglesClassical prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left) |
| Virtual prismatic adaptation | Experimental | Behavioral: Virtual reality devicevirtual prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left) |
| Imaged prismatic adaptation | Experimental | Behavioral: Prismatic gogglesImaged prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female
- Right-handed
- Aged 18 to 70
- Normal or corrected vision
- Signed written informed consent
Key exclusion criteria (4 listed)
- Neurological or psychiatric disorder
- Cognitive disorders
- presence of corrective eyeglasses
- Right upper limb orthopedic disorders
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 |
|---|---|---|
| Prismatic gogglesGoggles inducing a lateral displacement of the virtual field of ten degrees. Participants will be asked to wear those goggles during adaptation session and to perform pointing movement toward visual target. | Behavioural | Classical prismatic adaptation |
| Virtual reality deviceThe lateral displacement will be simulated thanks to a virtual reality environment. Participants will wear an Oculus Rift instead of the prismatic goggles and will perform pointing movement as well. | Behavioural | Virtual prismatic adaptation |
| Prismatic gogglesGoggles inducing a lateral displacement of the virtual field of ten degrees. Participants will be asked to wear those goggles during adaptation session and to mentally perform pointing movement toward visual target. There will be no concurrent movement execution. | Behavioural | Imaged prismatic adaptation |
Primary outcome
sensorimotor performances : measure of deviations in mm
Time frame: Day 0 - right before adaption
Task 1 : Line bisection to assess visuo-spatial bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Line bisection test, the reference point is the middle of the line.
Visuospatial performances : measure of deviations in mm
Time frame: Day 0 - right before adaption
Task 1 : Line bisection to assess visuo-spatial bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Line bisection test, the reference point is the middle of the line.
Visuospatial performances : measure of deviations in mm
Time frame: Day 0 - right after adaption
Task 1 : Line bisection to assess visuo-spatial bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Line bisection test, the reference point is the middle of the line.
sensorimotor performances : measure of deviations in mm
Time frame: Day 0 - right after adaption
Task 1 : Line bisection to assess visuo-spatial bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Line bisection test, the reference point is the middle of the line.
Visuospatial performances : measure of deviations in mm
Time frame: Day 0 - right before adaption
Task 2 : Goal-directed pointing to assess sensorimotor bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Goal-directed pointing test, the reference point is the target.
sensorimotor performances : measure of deviations in mm
Time frame: Day 0 - right before adaption
Task 2 : Goal-directed pointing to assess sensorimotor bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Goal-directed pointing test, the reference point is the target.
Visuospatial performances : measure of deviations in mm
Time frame: Day 0 - right after adaption
Task 2 : Goal-directed pointing to assess sensorimotor bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Goal-directed pointing test, the reference point is the target.
sensorimotor performances : measure of deviations in mm
Time frame: Day 0 - right after adaption
Task 2 : Goal-directed pointing to assess sensorimotor bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Goal-directed pointing test, the reference point is the target.
Visuospatial performances : measure of deviations in mm
Time frame: Day 0 - right before adaption
Task 3 : Straight Ahead pointing to assess proprioceptive bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Straight Ahead pointing and Visual judgement tests, the reference point is a central imaginary line
sensorimotor performances : measure of deviations in mm
Time frame: Day 0 - right before adaption
Task 3 : Straight Ahead pointing to assess proprioceptive bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Straight Ahead pointing and Visual judgement tests, the reference point is a central imaginary line
Visuospatial performances : measure of deviations in mm
Time frame: Day 0 - right after adaption
Task 3 : Straight Ahead pointing to assess proprioceptive bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Straight Ahead pointing and Visual judgement tests, the reference point is a central imaginary line
sensorimotor performances : measure of deviations in mm
Time frame: Day 0 - right after adaption
Task 3 : Straight Ahead pointing to assess proprioceptive bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Straight Ahead pointing and Visual judgement tests, the reference point is a central imaginary line
Visuospatial performances : measure of deviations in mm
Time frame: Day 0 - right before adaption
Task 4 : Visual judgement to assess visual bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
sensorimotor performances : measure of deviations in mm
Time frame: Day 0 - right before adaption
Task 4 : Visual judgement to assess visual bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
Visuospatial performances : measure of deviations in mm
Time frame: Day 0 - right after adaption
Task 4 : Visual judgement to assess visual bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
sensorimotor performances : measure of deviations in mm
Time frame: Day 0 - right after adaption
Task 4 : Visual judgement to assess visual bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point.
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 16 Apr 2026.
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Screening Protocol
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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.
Yves ROSSETTI, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prismatic goggles and Virtual reality device in people with Healthy Volunteers, run by Hospices Civils de Lyon 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 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: looking for participants now, as of the sponsor's last update on 16 Apr 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 Yves ROSSETTI, MD (04 72 91 34 12 ext. +33, yves.rossetti@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensorimotor performances : measure of deviations in mm (time frame: Day 0 - right before adaption). The study lists 16 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 16 Apr 2026.