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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)

Primary Purpose

Healthy Volunteers

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prismatic goggles
Virtual reality device
Prismatic goggles
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy Volunteers focused on measuring Virtual Reality, prismatic adaptation, motor imagery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lyon Neuroscience Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Classical prismatic adaptation

Virtual prismatic adaptation

Imaged prismatic adaptation

Arm Description

Classical prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left)

virtual prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left)

Imaged prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left)

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 27, 2018
Last Updated
January 30, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03807401
Brief Title
A Technical Innovation of Prismatic Adaptation Test in Healthy Subject, in Favour of Autonomy and Independence in Daily Life Following a Brain Injury
Acronym
PRIS'TUEL
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
April 8, 2024 (Anticipated)
Study Completion Date
April 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
Virtual Reality, prismatic adaptation, motor imagery

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Classical prismatic adaptation
Arm Type
Active Comparator
Arm Description
Classical prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left)
Arm Title
Virtual prismatic adaptation
Arm Type
Experimental
Arm Description
virtual prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left)
Arm Title
Imaged prismatic adaptation
Arm Type
Experimental
Arm Description
Imaged prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left)
Intervention Type
Behavioral
Intervention Name(s)
Prismatic goggles
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality device
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prismatic goggles
Intervention Description
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.
Primary Outcome Measure Information:
Title
sensorimotor performances : measure of deviations in mm
Description
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.
Time Frame
Day 0 - right before adaption
Title
Visuospatial performances : measure of deviations in mm
Description
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.
Time Frame
Day 0 - right before adaption
Title
Visuospatial performances : measure of deviations in mm
Description
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.
Time Frame
Day 0 - right after adaption
Title
sensorimotor performances : measure of deviations in mm
Description
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.
Time Frame
Day 0 - right after adaption
Title
Visuospatial performances : measure of deviations in mm
Description
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.
Time Frame
Day 0 - right before adaption
Title
sensorimotor performances : measure of deviations in mm
Description
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.
Time Frame
Day 0 - right before adaption
Title
Visuospatial performances : measure of deviations in mm
Description
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.
Time Frame
Day 0 - right after adaption
Title
sensorimotor performances : measure of deviations in mm
Description
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.
Time Frame
Day 0 - right after adaption
Title
Visuospatial performances : measure of deviations in mm
Description
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
Time Frame
Day 0 - right before adaption
Title
sensorimotor performances : measure of deviations in mm
Description
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
Time Frame
Day 0 - right before adaption
Title
Visuospatial performances : measure of deviations in mm
Description
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
Time Frame
Day 0 - right after adaption
Title
sensorimotor performances : measure of deviations in mm
Description
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
Time Frame
Day 0 - right after adaption
Title
Visuospatial performances : measure of deviations in mm
Description
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.
Time Frame
Day 0 - right before adaption
Title
sensorimotor performances : measure of deviations in mm
Description
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.
Time Frame
Day 0 - right before adaption
Title
Visuospatial performances : measure of deviations in mm
Description
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.
Time Frame
Day 0 - right after adaption
Title
sensorimotor performances : measure of deviations in mm
Description
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.
Time Frame
Day 0 - right after adaption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yves ROSSETTI, MD
Phone
04 72 91 34 12
Ext
+33
Email
yves.rossetti@inserm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro FARNE, PhD
Phone
04 72 91 34 12
Ext
+33
Email
Alessandro.farne@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves ROSSETTI, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lyon Neuroscience Research Center
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves ROSSETTI, MD
Phone
04 72 91 34 00
Ext
+33
Email
yves.rossetti@inserm.fr
First Name & Middle Initial & Last Name & Degree
Alessandro FARNE, PhD
Phone
04 72 91 34 12
Ext
+33
Email
Alessandro.farne@inserm.fr
First Name & Middle Initial & Last Name & Degree
Yves ROSSETTI, MD
First Name & Middle Initial & Last Name & Degree
Alessandro FARNE, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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