NCT02072460

Brief Summary

The present project aims at describing how vestibular signals contribute to the multisensory mechanisms of bodily self-consciousness. There is a large body of data regarding the sensory and neural mechanisms of self-consciousness, but most studies have so far demonstrated the contribution of visual, tactile and proprioceptive signals to bodily self-consciousness. Thus, most studies have neglected the contribution of the vestibular system, a major sensory system for spatial and bodily representations. The vestibular system is sensitive to head motions in space and head inclinations with respect to gravity and it should therefore contribute significantly to several bodily experiences. This contribution should be put under neuroscientific scrutiny. We believe that the current neuroscientific models of bodily self-consciousness will be incomplete until they incorporate the contribution of vestibular signals. The present project specifically aims at testing the hypothesis according to which vestibular signals significantly influence bodily self-consciousness, in particular first-person and third-person perspective taking and the internal body models (i.e. the body schema and body image). The present project also aims at describing how cortical vestibular processing is modified during experimental changes of perspective taking and viewpoint. In addition, the present project will describe whether vestibular disorders change performances in third-person perspective taking tasks and modify internal body models. This should help understanding bodily symptoms in vestibular-defective patients. To this end, we will combine approaches from psychophysics and electrophysiology (electromyography, electroencephalography) in healthy volunteers and behavioral approached in patients with vestibular disorders. These studies should further the understanding of how the brain processes vestibular signals, which is to date poorly understood. In addition, the outcome of the present project should help understanding the multiple and complex symptoms reported by patients with vestibular diseases, and should therefore improve their treatment.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

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

November 14, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Last Updated

February 26, 2014

Status Verified

February 1, 2014

Enrollment Period

3.4 years

First QC Date

November 14, 2013

Last Update Submit

February 24, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • vestibular signals

    testing the hypothesis according to which vestibular signals significantly influence bodily self-consciousness, in particular first-person and third-person perspective taking and the internal body models (i.e. the body schema and body image).

    48 months

Study Arms (1)

vestibular signals determination

EXPERIMENTAL

vestibular signals determination by electromyography and electroencephalography associated to approaches from psychophysics

Other: electromyographyOther: electroencephalographyOther: approaches from psychophysics

Interventions

vestibular signals determination
vestibular signals determination
vestibular signals determination

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with chirurgical treatment for Meuniere disease or accoustic neurinoma or with acute vestibular deficiency.

You may not qualify if:

  • Patient with neurological history
  • Patient with a lack of motricity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Interventions

Neurofeedback

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Loïc MONDOLONI

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2013

First Posted

February 26, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2017

Last Updated

February 26, 2014

Record last verified: 2014-02

Locations