NCT05198440

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)).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable healthy

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

January 30, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

December 7, 2021

Last Update Submit

January 14, 2022

Conditions

Keywords

vectionneuromodulationrTMStACS

Outcome Measures

Primary Outcomes (4)

  • Change in the latency of first vection between neuromodulations

    Time required for the appearance of a vection before and after neurostimulation (latency in s).

    During the two experimental sessions, at day 1 and up to day 15

  • Change in the vection frequency between neuromodulations

    Frequency of vection episodes during a period of visual stimulation before and after neurostimulation (%).

    During the two experimental sessions, at day 1 and up to day 15

  • Change in the vection duration between neuromodulations

    Perceived total time experiencing vection during visual stimulation before and after neurostimulation (s).

    During the two experimental sessions, at day 1 and up to day 15

  • Change in the vection intensity between neuromodulations

    Intensity of vection before and after neurostimulation (subjective scale from 0 to 10).

    During the two experimental sessions, at day 1 and up to day 15

Secondary Outcomes (3)

  • Change in brain activity (as measured by EEG - EP) between neuromodulations

    During the two experimental sessions, at day 1 and up to day 15

  • Change in brain activity (as measured by EEG - spectrum) between neuromodulations

    During the two experimental sessions, at day 1 and up to day 15

  • Change in brain activity (as measured by EEG - connectivity) between neuromodulations

    During the two experimental sessions, at day 1 and up to day 15

Study Arms (1)

Neuromodulation of vection

EXPERIMENTAL
Device: non-invasive neuromodulationDevice: electroencephalographyDevice: anatomical MRI

Interventions

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).

Also known as: rTMS, tACS
Neuromodulation of vection

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).

Also known as: EEG
Neuromodulation of vection

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).

Neuromodulation of vection

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Electroencephalography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 7, 2021

First Posted

January 20, 2022

Study Start

January 30, 2022

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

January 20, 2022

Record last verified: 2022-01