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HIERARCHY OF VISION (HIERARCHY)

Primary Purpose

Neurologic Signs

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
functional Magnetic Resonance Imaging
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neurologic Signs focused on measuring Vision, perception, BOLD activity

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged between 18 and 40 years old
  • Affiliated to a social security scheme
  • Be right-handed
  • Have signed the informed consent

Exclusion Criteria:

  • Subjects with a neurological or psychiatric history
  • Subjects with visual disturbances not corrected
  • Pregnant, lactating or childbearing women without contraception.
  • Persons under guardianship, trusteeship or any other administrative or judicial measure of deprivation of rights or liberty, as well as adults protected by law.
  • Participants refusing to be informed of the results of the medical examination.
  • Participants refusing to be informed of the possible detection of an anomaly.
  • Volunteers with contraindications to the MRI examination: people using a pacemaker or an insulin pump, persons wearing a metal prosthesis or an intracerebral clip as well as claustrophobic subjects, neurosensory stimulator or implantable defibrillator, cochlear implants, ferromagnetic foreign body ocular or cerebral close to the nerve structures, agitation of the subject (non-cooperating or agitated subjects), ventriculoperitoneal neurosurgical bypass valves, dental apparatus.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    healthy subjects

    Arm Description

    25 healthy subjects with a normal/corrected vision fitting to all of the inclusion/exclusion criteria. All the subjects will be tested on the same visual stimuli, leading to intrasubject comparison analyses of functional magnetic resonance imaging (fMRI) activity between conditions.

    Outcomes

    Primary Outcome Measures

    Non-invasive Blood oxygenation level dependent (BOLD) fMRI activity
    Blood oxygenation level dependent (BOLD) imaging is the standard technique used to generate images in fMRI studies, and relies on regional differences in cerebral blood flow to delineate regional activity. This non-invasive technic is not inducing any particular risk. The non invasive BOLD fMRI activity will be recorded in healthy subjects during a task of visual perception.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 4, 2019
    Last Updated
    February 23, 2021
    Sponsor
    Hospices Civils de Lyon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03905616
    Brief Title
    HIERARCHY OF VISION
    Acronym
    HIERARCHY
    Official Title
    Hierarchical Processing of Visual Movement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    abandonment
    Study Start Date
    July 22, 2019 (Actual)
    Primary Completion Date
    February 17, 2021 (Actual)
    Study Completion Date
    February 17, 2021 (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
    Little is known about the exact role of feedback in cortical processing. Hypotheses on its function range from attentional control to the transmission of Bayesian priors in the interpretation of sensory events, such as in the theory of Predictive Coding. Recent advances in identification of functional signatures of feedback and feedforward signal, as well as additional techniques based on causal relations in signal processing open a unique methodology for probing such processes in awake and behaving organisms and testing these theories and more generally the hierarchical processing between cortical areas. The objective of this project is to study feedback and feedforward relations and localization in the well established pathways between cortical areas V1 and Medial Temporal (MT) that have been implicated in early integration processes in motion perception.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neurologic Signs
    Keywords
    Vision, perception, BOLD activity

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    healthy subjects
    Arm Type
    Experimental
    Arm Description
    25 healthy subjects with a normal/corrected vision fitting to all of the inclusion/exclusion criteria. All the subjects will be tested on the same visual stimuli, leading to intrasubject comparison analyses of functional magnetic resonance imaging (fMRI) activity between conditions.
    Intervention Type
    Device
    Intervention Name(s)
    functional Magnetic Resonance Imaging
    Intervention Description
    In a 2-hour session, the subject we be shown different control and experimental conditions (all being visual stimuli) in perceptive tasks.
    Primary Outcome Measure Information:
    Title
    Non-invasive Blood oxygenation level dependent (BOLD) fMRI activity
    Description
    Blood oxygenation level dependent (BOLD) imaging is the standard technique used to generate images in fMRI studies, and relies on regional differences in cerebral blood flow to delineate regional activity. This non-invasive technic is not inducing any particular risk. The non invasive BOLD fMRI activity will be recorded in healthy subjects during a task of visual perception.
    Time Frame
    At inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Aged between 18 and 40 years old Affiliated to a social security scheme Be right-handed Have signed the informed consent Exclusion Criteria: Subjects with a neurological or psychiatric history Subjects with visual disturbances not corrected Pregnant, lactating or childbearing women without contraception. Persons under guardianship, trusteeship or any other administrative or judicial measure of deprivation of rights or liberty, as well as adults protected by law. Participants refusing to be informed of the results of the medical examination. Participants refusing to be informed of the possible detection of an anomaly. Volunteers with contraindications to the MRI examination: people using a pacemaker or an insulin pump, persons wearing a metal prosthesis or an intracerebral clip as well as claustrophobic subjects, neurosensory stimulator or implantable defibrillator, cochlear implants, ferromagnetic foreign body ocular or cerebral close to the nerve structures, agitation of the subject (non-cooperating or agitated subjects), ventriculoperitoneal neurosurgical bypass valves, dental apparatus.

    12. IPD Sharing Statement

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