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

NCT03807401 | Recruiting

• 2 other identifiers: 69HCL18_07212018-A03175-50
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Virtual Reality; prismatic adaptation; motor imagery

Outcome Measures

Primary Outcomes (16)

• 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

Study Arms (3)

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)

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)

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)

Behavioral: Prismatic goggles

Interventions

Prismatic goggles BEHAVIORAL

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.

Classical prismatic adaptation

Virtual reality device BEHAVIORAL

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.

Virtual prismatic adaptation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Lyon Neuroscience Research Center

Bron, 69500, France

RECRUITING

Study Officials

• Yves ROSSETTI, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves ROSSETTI, MD

CONTACT

04 72 91 34 12; yves.rossetti@inserm.fr

Alessandro FARNE, PhD

CONTACT

04 72 91 34 12; Alessandro.farne@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: January 16, 2019
• Study Start: October 8, 2019
• Primary Completion (Estimated): April 8, 2028
• Study Completion (Estimated): April 8, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

FR (1)