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Neuromodulation of Motion Illusions (Vection) (NEUROVEC)

Primary Purpose

Healthy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
non-invasive neuromodulation
electroencephalography
anatomical MRI
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring vection, neuromodulation, rTMS, tACS

Eligibility Criteria

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

Inclusion Criteria:

  • Healthy subjects aged 18 to 40 years
  • Right-handed subjects
  • Signed informed consent,
  • Medical examination performed prior to participation in the research,
  • Affiliation to or beneficiary of a social security plan

Exclusion Criteria:

  • Contraindications (CI) to the practice of MRI, EEG, TMS & tES
  • Existence of a severe general condition: cardiac, respiratory, hematological, renal, hepatic, cancerous,
  • Regular use of anxiolytics, sedatives, antidepressants, neuroleptics,
  • Characterized psychiatric pathology,
  • Ingestion of alcohol before the examination,
  • Pregnant, parturient or breastfeeding women
  • Person deprived of liberty by judicial or administrative decision, person under a legal protection measure (under guardianship or curators)
  • Participation in other interventional research protocols in progress with an exclusion period or in the previous week Subject who would receive more than 4500 euros of compensation due to his participation in other research involving the human person in the 12 months preceding this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Neuromodulation of vection

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in the latency of first vection between neuromodulations
    Time required for the appearance of a vection before and after neurostimulation (latency in s).
    Change in the vection frequency between neuromodulations
    Frequency of vection episodes during a period of visual stimulation before and after neurostimulation (%).
    Change in the vection duration between neuromodulations
    Perceived total time experiencing vection during visual stimulation before and after neurostimulation (s).
    Change in the vection intensity between neuromodulations
    Intensity of vection before and after neurostimulation (subjective scale from 0 to 10).

    Secondary Outcome Measures

    Change in brain activity (as measured by EEG - EP) between neuromodulations
    - Evoked potentials (V)
    Change in brain activity (as measured by EEG - spectrum) between neuromodulations
    - Oscillatory activity (V^2 / Hz)
    Change in brain activity (as measured by EEG - connectivity) between neuromodulations
    - Functional connectivity (%)

    Full Information

    First Posted
    December 7, 2021
    Last Updated
    January 14, 2022
    Sponsor
    University Hospital, Grenoble
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05198440
    Brief Title
    Neuromodulation of Motion Illusions (Vection)
    Acronym
    NEUROVEC
    Official Title
    Neuromodulation of Motion Illusions (Vection)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 30, 2022 (Anticipated)
    Primary Completion Date
    January 30, 2024 (Anticipated)
    Study Completion Date
    January 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital, Grenoble

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Virtual reality systems or simulators are more and more frequently used in the field of learning but also in motor rehabilitation. One of the key points of the success of these systems is the experience of "presence" which is associated with the capacity of these technologies to develop in the observer, who is static, the sensation of moving in the virtual environment (vection). However, the simulation generates a sensory conflict (an optical flow specifying self-motion and vestibular stimuli specifying body immobility). This conflict influences the temporal characteristics of the vection and consequently modifies the way users act in their virtual environment. Thus, contrary to a real situation, vection does not occur instantaneously with the appearance of a visual movement. Moreover, the visual stimulus often generates alternating periods of perception of movement of the environment and of oneself (bistable perception) which can lead to "simulator sickness", a disabling situation for the user. Thus, as vection is an essential element to allow an "optimal transfer of learning" from the simulator to reality, it may be important to promote its emergence while limiting its bistability. The aim of this project is to study the inhibitory or facilitative modulation of the emergence of the vection phenomenon by the use of non-invasive cortical stimulation techniques (transcranial electrical stimulation (tES), transcranial alternative current stimulation (tACS), and repeated transcranial magnetic stimulation (rTMS)).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy
    Keywords
    vection, neuromodulation, rTMS, tACS

    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
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Neuromodulation of vection
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    non-invasive neuromodulation
    Other Intervention Name(s)
    rTMS, tACS
    Intervention Description
    The modulations of the vection phenomenon will then be studied over two sessions of 1h30, separated by a minimum of 3 to a maximum of 15 days (the first session will be performed following the MRI). Each session will include: the installation of an EEG headset and the parameterization of the stimulation (30 min), then a phase of recording of the vection with neuromodulation (1h) according to 2 experimental conditions: Experiment 1: recording of vection at rest (20 min), then during and after neurostimulation by tES (20 min). Active and sham (placebo) stimulation will be tested separately during the two sessions (counterbalanced order). Experiment 2: recording of vection during neuromodulation by rTMS triggered in real time (1h). Triggering will be based on behavioral response (experiment 2a) or oscillatory activity detection (experiment 2b). Active and sham (placebo) stimulation will be tested in both sessions (randomized order).
    Intervention Type
    Device
    Intervention Name(s)
    electroencephalography
    Other Intervention Name(s)
    EEG
    Intervention Description
    The modulations of the vection phenomenon will then be studied over two sessions of 1h30, separated by a minimum of 3 to a maximum of 15 days (the first session will be performed following the MRI). Each session will include: the installation of an EEG headset and the parameterization of the stimulation (30 min), then a phase of recording of the vection with neuromodulation (1h) according to 2 experimental conditions: Experiment 1: recording of vection at rest (20 min), then during and after neurostimulation by tES (20 min). Active and sham (placebo) stimulation will be tested separately during the two sessions (counterbalanced order). Experiment 2: recording of vection during neuromodulation by rTMS triggered in real time (1h). Triggering will be based on behavioral response (experiment 2a) or oscillatory activity detection (experiment 2b). Active and sham (placebo) stimulation will be tested in both sessions (randomized order).
    Intervention Type
    Device
    Intervention Name(s)
    anatomical MRI
    Intervention Description
    The modulations of the vection phenomenon will then be studied over two sessions of 1h30, separated by a minimum of 3 to a maximum of 15 days (the first session will be performed following the MRI). Each session will include: the installation of an EEG headset and the parameterization of the stimulation (30 min), then a phase of recording of the vection with neuromodulation (1h) according to 2 experimental conditions: Experiment 1: recording of vection at rest (20 min), then during and after neurostimulation by tES (20 min). Active and sham (placebo) stimulation will be tested separately during the two sessions (counterbalanced order). Experiment 2: recording of vection during neuromodulation by rTMS triggered in real time (1h). Triggering will be based on behavioral response (experiment 2a) or oscillatory activity detection (experiment 2b). Active and sham (placebo) stimulation will be tested in both sessions (randomized order).
    Primary Outcome Measure Information:
    Title
    Change in the latency of first vection between neuromodulations
    Description
    Time required for the appearance of a vection before and after neurostimulation (latency in s).
    Time Frame
    During the two experimental sessions, at day 1 and up to day 15
    Title
    Change in the vection frequency between neuromodulations
    Description
    Frequency of vection episodes during a period of visual stimulation before and after neurostimulation (%).
    Time Frame
    During the two experimental sessions, at day 1 and up to day 15
    Title
    Change in the vection duration between neuromodulations
    Description
    Perceived total time experiencing vection during visual stimulation before and after neurostimulation (s).
    Time Frame
    During the two experimental sessions, at day 1 and up to day 15
    Title
    Change in the vection intensity between neuromodulations
    Description
    Intensity of vection before and after neurostimulation (subjective scale from 0 to 10).
    Time Frame
    During the two experimental sessions, at day 1 and up to day 15
    Secondary Outcome Measure Information:
    Title
    Change in brain activity (as measured by EEG - EP) between neuromodulations
    Description
    - Evoked potentials (V)
    Time Frame
    During the two experimental sessions, at day 1 and up to day 15
    Title
    Change in brain activity (as measured by EEG - spectrum) between neuromodulations
    Description
    - Oscillatory activity (V^2 / Hz)
    Time Frame
    During the two experimental sessions, at day 1 and up to day 15
    Title
    Change in brain activity (as measured by EEG - connectivity) between neuromodulations
    Description
    - Functional connectivity (%)
    Time Frame
    During the two experimental sessions, at day 1 and up to day 15

    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: Healthy subjects aged 18 to 40 years Right-handed subjects Signed informed consent, Medical examination performed prior to participation in the research, Affiliation to or beneficiary of a social security plan Exclusion Criteria: Contraindications (CI) to the practice of MRI, EEG, TMS & tES Existence of a severe general condition: cardiac, respiratory, hematological, renal, hepatic, cancerous, Regular use of anxiolytics, sedatives, antidepressants, neuroleptics, Characterized psychiatric pathology, Ingestion of alcohol before the examination, Pregnant, parturient or breastfeeding women Person deprived of liberty by judicial or administrative decision, person under a legal protection measure (under guardianship or curators) Participation in other interventional research protocols in progress with an exclusion period or in the previous week Subject who would receive more than 4500 euros of compensation due to his participation in other research involving the human person in the 12 months preceding this study

    12. IPD Sharing Statement

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    Neuromodulation of Motion Illusions (Vection)

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