Vestibular-defective PatientsNCT01900457
Vestibular and Multisensory Influence on Bodily and Spatial Representations. Behavioral and Electrophysiological Investigations in Vestibular-defective Patients and Healthy Volunteers
A study testing electromyography, electroencephalography and approaches from psychophysics in people with Vestibular-defective Patients, 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-defective Patients
- What is being tested?
- electromyography, electroencephalography and approaches from psychophysics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Oct 2013
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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-defective Patients
- 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 |
|---|---|---|
| Volunteer healthy | Active comparator | healthy volunteers Receives: Other: approaches from psychophysics |
| patients | Experimental | vestibular defective patients Receives: Other: electromyography; Other: electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
vestibular signals
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startJun 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular-defective PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900457
- Sponsor's protocol ID
- 2011-A01221-40
- Other IDs
- 2013-18
- Status last verified
- Apr 2015
- First submitted
- 12 Jul 2013
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. 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
- NCT01900457
- Acronym / sponsor ID
- 2011-A01221-40
- Conditions
- Vestibular-defective Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 16 Jul 2013 (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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volunteer healthy | Active comparator | Other: approaches from psychophysicshealthy volunteers |
| patients | Experimental | Other: electromyography, Other: electroencephalographyvestibular defective patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 | patients |
| electroencephalography | Other | patients |
| approaches from psychophysics | Other | Volunteer healthy |
Primary outcome
vestibular signals
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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.
LOIC 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-defective Patients, 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 21 Apr 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 4 years). 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 21 Apr 2015.