Vestibular DisordersNCT02072460
Vestibular and Multisensory Influence on Bodily and Spatial Representations
A study testing electromyography, electroencephalography and approaches from psychophysics in people with Vestibular Disorders, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disorders
- What is being tested?
- electromyography, electroencephalography and approaches from psychophysics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with chirurgical treatment for Meuniere disease or accoustic neurinoma or with acute vestibular deficiency.
Who cannot join
- Patient with neurological history
- Patient with a lack of motricity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vestibular and Multisensory Influence on Bodily and Spatial Representations. Behavioral and Electrophysiological Investigations in Vestibular-defective Patients and Healthy Volunteers
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.
Read more
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.
- Conditions
- Vestibular Disorders
- Being tested
- electromyography, electroencephalography, approaches from psychophysics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electromyographyOther
electroencephalographyOther
approaches from psychophysicsOther
| Study group | Role | What they receive |
|---|---|---|
| vestibular signals determination | Experimental | vestibular signals determination by electromyography and electroencephalography associated to approaches from psychophysics Receives: Other: electromyography; Other: electroencephalography; Other: approaches from psychophysics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loïc MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072460
- Sponsor's protocol ID
- 2013-A00691-44
- Other IDs
- 2013-18
- Status last verified
- Feb 2014
- First submitted
- 14 Nov 2013
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular and Multisensory Influence on Bodily and Spatial Representations. Behavioral and Electrophysiological Investigations in Vestibular-defective Patients and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02072460
- Acronym / sponsor ID
- 2013-A00691-44
- Conditions
- Vestibular Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2017 (estimated)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vestibular signals determination | Experimental | Other: electromyography, Other: electroencephalography, Other: approaches from psychophysicsvestibular signals determination by electromyography and electroencephalography associated to approaches from psychophysics |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with chirurgical treatment for Meuniere disease or accoustic neurinoma or with acute vestibular deficiency.
Key exclusion criteria (2 listed)
- Patient with neurological history
- Patient with a lack of motricity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electromyography | Other | vestibular signals determination |
| electroencephalography | Other | vestibular signals determination |
| approaches from psychophysics | Other | vestibular signals determination |
Primary outcome
vestibular signals
Time frame: 48 months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loïc MONDOLONI study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electromyography, electroencephalography and approaches from psychophysics in people with Vestibular Disorders, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vestibular signals (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2014.