NCT01900457

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

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

July 12, 2013

Last Update Submit

April 20, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • vestibular signals

    4 years

Study Arms (2)

Volunteer healthy

ACTIVE COMPARATOR

healthy volunteers

Other: approaches from psychophysics

patients

EXPERIMENTAL

vestibular defective patients

Other: electromyographyOther: electroencephalography

Interventions

patients
Volunteer healthy

Eligibility Criteria

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

You may qualify if:

  • men(people) or women from 18 to 65 years old
  • patients having benefited from a surgical operation (neurotomie vestibulaire unilateral) within the framework of a disease of invalidating Ménière or a neurinome of the accoustique, or patients with an acute(sharp) infringement(achievement) of the system vestibulaire.

You may not qualify if:

  • The patients suffering from an additional hurt of the central nervous system,
  • the patients suffering from driving infringements(achievements),
  • the subjects having neurological histories (other than those led(inferred) by the disorders(confusions) vestibulaires) or psychiatric,
  • the vulnerable persons aimed by articles L. 1121-5, L. 1121-6 and L. 1121-8,
  • the persons unfit of the reading and the writing of French not allowing the understanding of the note of information and the form of consent

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

  • LOIC MONDOLONI

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2013

First Posted

July 16, 2013

Study Start

June 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations