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NCT Number: NCT03807401

A Technical Innovation of Prismatic Adaptation Test in Healthy Subject, 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lyon Neuroscience Research Center

Bron, 69500, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

To Simulate Prismatic Adaptation in Healthy Subject : a Technical Innovation in Favour of Autonomy and Independence in Daily Life Following a Brain Injury

Acronym: PRIS'TUEL

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Jan 16, 2019
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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