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

NCT ID: NCT03807401

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-08
• Study Completion Date: 2026-04-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Classical prismatic adaptation

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

Group Type: ACTIVE_COMPARATOR

Prismatic goggles

Intervention Type: 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.

Virtual prismatic adaptation

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

Group Type: EXPERIMENTAL

Virtual reality device

Intervention Type: 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.

Imaged prismatic adaptation

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

Group Type: EXPERIMENTAL

Prismatic goggles

Intervention Type: 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 mentally perform pointing movement toward visual target. There will be no concurrent movement execution.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yves ROSSETTI, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Lyon Neuroscience Research Center

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Yves ROSSETTI, MD

Role: CONTACT

yves.rossetti@inserm.fr

04 72 91 34 12 ext. +33

Alessandro FARNE, PhD

Role: CONTACT

Alessandro.farne@inserm.fr

04 72 91 34 12 ext. +33

Facility Contacts

Yves ROSSETTI, MD

Role: primary

yves.rossetti@inserm.fr

04 72 91 34 00 ext. +33

Alessandro FARNE, PhD

Role: backup

Alessandro.farne@inserm.fr

04 72 91 34 12 ext. +33

Other Identifiers

2018-A03175-50

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL18_0721

Identifier Type: -

Identifier Source: org_study_id