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Eye Movements and Visuo-spatial Perception

Primary Purpose

Cerebellum Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Forward adaptation of reactive saccades
Backward adaptation of reactive saccades
Execution of reactive saccades
Generation of reactive saccades
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebellum Disease focused on measuring cerebellar lesion, saccadic adaptation, spatial localization, visuo spatial perception, eye movements

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age : from 18 to 80 ans included
  • Visual acuity monocularly at distance and near corrected : > 5/10
  • Possible understanding of experimental guidelines
  • Possible respect for sustained seated position
  • Subject covered by social security
  • Agreement of the subject

Inclusion Criteria, specific to Axe 1:

  • Cerebellar patients - Cerebellar degenerative disease (group A) or stroke (group B, délai depuis l'AVC : delay from the stroke : at least 1 month)

    • Scanner or MRI showing diffuse atrophy (group A) or focal cerebellar lesion (group B)
  • Healthy subjects

    • Absence of known ophtalmological or neurological pathology

Inclusion Criteria, specific to Axe 2:

  • Stroke patients - ischemic or hemorrhagic stroke

    • Encephalic MRI or CT scan showing an unique lesion
    • Minimal delay of one year after the stroke

Exclusion Criteria:

  • Visual acuity monocularly < 5/10
  • Language disorder restricting oral and reading comprehension of the study
  • Severe disability limiting the maintenance of sitting position and concentration capacities for a period of 30 minutes consecutive
  • Poor French language skills
  • Non-stabilized medical condition
  • Psychotropic medication intake
  • Pregnant and / or nursing women
  • Subject under guardianship or curatorship
  • Subject frequently in healthcare or social care for purposes other than research
  • Subject deprived of liberty by a judicial or administrative decision

Exclusion Criteria, specific to Axe 1:

• Cerebellar patients

- Disorders prohibiting the correct performance of the task (tremor, ocular instability)

Exclusion Criteria, specific to Axe 2:

• Stroke patients

  • Hemianopsia homonima lateral
  • Neurological degenerative disease

Sites / Locations

  • Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

FORWARD (Axe 1)

BACKWARD (Axe 1)

CONTROL (Axe 1)

ADAPTATION (Axe 2)

CONTROL (Axe 2)

Arm Description

Outcomes

Primary Outcome Measures

Saccadic adaptation efficiency
〖Adaptation〗_rate= (〖Amplitude 〗_post-〖Amplitude 〗_pre)/〖Amplitude 〗_pre

Secondary Outcome Measures

Evolution of localization-task performances
〖Improvement〗_performances= (〖Mislocalization 〗_post-〖Mislocalization 〗_pre)/〖Mislocalization 〗_pre
Evolution of attentional performances assessed by neuropsychological tests of neglect
〖Improvement〗_performances= (〖Score 〗_post-〖Score〗_pre)/〖Score〗_pre

Full Information

First Posted
March 29, 2017
Last Updated
April 20, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03112408
Brief Title
Eye Movements and Visuo-spatial Perception
Official Title
Coupling Between Adaptation of Saccadic Eye Movements and Visuo-spatial Perception and Attention Processes: a Behavioural Study in Humans.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
October 2, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)

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
This research aims to highlight the key roles of the cerebellar and cortical fronto-parietal networks in the coupling of eye movements with visual perception and visuo-spatial attention.
Detailed Description
The first axe of this research focuses on the role of the cerebellum which has a major contribution to sensorimotor adaptation and more precisely in saccadic adaptation but the nature of this contribution is still debated. A classical assumption stipulates cerebellum has an exclusive action on saccadic burst generator in the brainstem whereas recent data increasingly support the view that cerebellum could also modulates cerebral cortex through a cerebello-thalamo-cortical pathway. On the other hand, several studies have shown that modification of saccade amplitude by saccadic adaptation leads to a distortion of the visual localization of briefly flashed spatial probes but no study to date has tested, the contribution of the cerebellum in these adaptation-induced mislocalizations. The main objective of this axe is to define the role of the cerebellum not only in saccadic adaptation, but also in mislocalizations which occur after adaptation. Moreover, in testing this assumption, arguments in favour -or in disfavor- of the action of the cerebellum on cortical stages dedicated to visuo-spatial perceptual processing will be provided. Besides, variability of cerebellar lesion (or cerebellar dysfunction) location in patients can lead to different pattern in saccadic adaptation and localization task performances. Identification of dissociations between these two abilities in some patients will define more precisely the role of the cerebellum in the coupling between saccadic adaptation and visuo spatial perception as an oculomotor plasticity territory and / or as a territory underlying the error signal coding generating this type of plasticity. This second axe of this research aims to apply basic findings in healthy subject on the coupling between oculomotor plasticity and spatial attention to patients with parietal lesion, in order to evaluate a rehabilitation procedure for neglect patients. Habchi and colleagues showed that the adaptation of reactive saccades in the left hemifield has a boosting effect on attentional performance in the same hemifield. The coupling between these two mechanisms highlighted in healthy subjects can be used as fundamentals in the elaboration of a rehabilitation procedure for attentional disorders in the neglect syndrome. This syndrome is mainly observed after cerebral lesions in the right hemisphere, and is characterized by very disabling cognitive disorders such as an alteration of the spatial representation of left hemi-space and/or left hemi-body. stimulation of sensorimotor plasticity thanks to prismatic adaptation could be used as a rehabilitation procedure for this syndrome. Being another efficient way to stimulate sensorimotor plasticity, the equip believe that saccadic adaptation can also be used as a rehabilitation procedure for neglect patients. Moreover, due to its tight coupling with visual attention, the benefits of saccadic adaptation could be even stronger and longer lasting than the visuo-manual plasticity induced by prismatic adaptation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellum Disease
Keywords
cerebellar lesion, saccadic adaptation, spatial localization, visuo spatial perception, eye movements

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FORWARD (Axe 1)
Arm Type
Experimental
Arm Title
BACKWARD (Axe 1)
Arm Type
Experimental
Arm Title
CONTROL (Axe 1)
Arm Type
Experimental
Arm Title
ADAPTATION (Axe 2)
Arm Type
Experimental
Arm Title
CONTROL (Axe 2)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Forward adaptation of reactive saccades
Intervention Description
Protocol of reactive saccade where the target is displaced in the same direction as the saccade in order to induce an adaptive increase of saccade amplitude ('forward adaptation')
Intervention Type
Behavioral
Intervention Name(s)
Backward adaptation of reactive saccades
Intervention Description
Protocol of reactive saccade where the target is displaced in a direction opposite to the saccade in order to induce an adaptive decrease of saccade amplitude ('backward adaptation')
Intervention Type
Behavioral
Intervention Name(s)
Execution of reactive saccades
Intervention Description
Control protocol of reactive saccade with no displacement of the saccadic target (controlling for non specific factors possibly involved in forward and backward adaptation conditions)
Intervention Type
Behavioral
Intervention Name(s)
Generation of reactive saccades
Intervention Description
Control protocol of reactive saccade with no displacement of the saccadic target (controlling for non specific factors possibly involved in adaptation condition)
Primary Outcome Measure Information:
Title
Saccadic adaptation efficiency
Description
〖Adaptation〗_rate= (〖Amplitude 〗_post-〖Amplitude 〗_pre)/〖Amplitude 〗_pre
Time Frame
At time of each experimental session, up to 2 months, since first experimental visit until last visit
Secondary Outcome Measure Information:
Title
Evolution of localization-task performances
Description
〖Improvement〗_performances= (〖Mislocalization 〗_post-〖Mislocalization 〗_pre)/〖Mislocalization 〗_pre
Time Frame
At time of each experimental session, up to 2 months, since first experimental visit until last visit
Title
Evolution of attentional performances assessed by neuropsychological tests of neglect
Description
〖Improvement〗_performances= (〖Score 〗_post-〖Score〗_pre)/〖Score〗_pre
Time Frame
At time of each experimental session, up to 2 months, since first experimental visit until last visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age : from 18 to 80 ans included Visual acuity monocularly at distance and near corrected : > 5/10 Possible understanding of experimental guidelines Possible respect for sustained seated position Subject covered by social security Agreement of the subject Inclusion Criteria, specific to Axe 1: Cerebellar patients - Cerebellar degenerative disease (group A) or stroke (group B, délai depuis l'AVC : delay from the stroke : at least 1 month) Scanner or MRI showing diffuse atrophy (group A) or focal cerebellar lesion (group B) Healthy subjects Absence of known ophtalmological or neurological pathology Inclusion Criteria, specific to Axe 2: Stroke patients - ischemic or hemorrhagic stroke Encephalic MRI or CT scan showing an unique lesion Minimal delay of one year after the stroke Exclusion Criteria: Visual acuity monocularly < 5/10 Language disorder restricting oral and reading comprehension of the study Severe disability limiting the maintenance of sitting position and concentration capacities for a period of 30 minutes consecutive Poor French language skills Non-stabilized medical condition Psychotropic medication intake Pregnant and / or nursing women Subject under guardianship or curatorship Subject frequently in healthcare or social care for purposes other than research Subject deprived of liberty by a judicial or administrative decision Exclusion Criteria, specific to Axe 1: • Cerebellar patients - Disorders prohibiting the correct performance of the task (tremor, ocular instability) Exclusion Criteria, specific to Axe 2: • Stroke patients Hemianopsia homonima lateral Neurological degenerative disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Tilikete, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Eye Movements and Visuo-spatial Perception

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