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
About this trial
This is an interventional basic science trial for Healthy focused on measuring vection, neuromodulation, rTMS, tACS
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
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
NCT ID
NCT05198440
First Posted
December 7, 2021
Last Updated
January 14, 2022
Sponsor
University Hospital, Grenoble
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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