A Technical Innovation of Prismatic Adaptation Test in Healthy Subject, in Favour of Autonomy and Independence in Daily Life Following a Brain Injury (PRIS'TUEL)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Behavioral: Prismatic goggles; Behavioral: Prismatic goggles; Behavioral: Virtual reality device

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yves ROSSETTI, MD; Phone Number: +33 04 72 91 34 12; Email: yves.rossetti@inserm.fr
• Study Contact Backup: Name: Alessandro FARNE, PhD; Phone Number: +33 04 72 91 34 12; Email: Alessandro.farne@inserm.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Lyon Neuroscience Research Center
    • Contact: Alessandro FARNE, PhD; Phone Number: +33 04 72 91 34 12; Email: Alessandro.farne@inserm.fr
    • Contact: Yves ROSSETTI, MD; Phone Number: +33 04 72 91 34 00; Email: yves.rossetti@inserm.fr
    • Principal Investigator: Yves ROSSETTI, MD
    • Sub-Investigator: Alessandro FARNE, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female
• Right-handed
• Aged 18 to 70
• Normal or corrected vision
• Signed written informed consent
• Affiliated to a health care organism.

Exclusion Criteria:

• Neurological or psychiatric disorder
• Cognitive disorders
• presence of corrective eyeglasses
• Right upper limb orthopedic disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Classical prismatic adaptation; Classical prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left)	Behavioral: Prismatic goggles; 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.; Behavioral: Prismatic goggles; 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.
Experimental: Virtual prismatic adaptation; virtual prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left)	Behavioral: Virtual reality device; 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.
Experimental: Imaged prismatic adaptation; Imaged prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left)	Behavioral: Prismatic goggles; 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.; Behavioral: Prismatic goggles; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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	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	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	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	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.	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.	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.	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.	Day 0 - right after adaption

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Yves ROSSETTI, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Estimated): April 8, 2026
• Study Completion (Estimated): April 8, 2026

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Reality; motor imagery; prismatic adaptation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: 69HCL18_0721; 2018-A03175-50 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No