Proof of Concept Study Concerning Vestibular Stimulation Using a New Method of Dynamic Posturography.

Vestibular Stimulation Clinical Trial

— POSTURODYN  

Official title:

Proof of Concept Study Concerning Vestibular Stimulation Using a New Method of Dynamic Posturography.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851524
• Other study ID #: REVERCHON AOI 2015
• Status: Completed
• Phase: N/A
• Start date: June 23, 2016
• Est. completion date: April 21, 2017

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Falls in the elderly population are a major public health problem because of their frequency and their consequences, notably in terms of dependence their cost to society. In most cases, balance disorders related to an impaired vestibular system are blamed, even though there is no formal evidence that this is the case.

Vestibular tests in routine otoneurological practice are based on the exploration of vestibulo-ocular or even vestibulo-cortical reflexes. They are not particularly suitable to screen for vestibular disorders in falls.

A prototype rocking chair has been developed to test psycho-vestibular pathways, defined as the pathways via which vestibular afferents are transported to the subject's conscience. Thanks to this apparatus, a stimulus of body movement will be generated, but with limited tactile, visual and proprioceptive afferents, in such a way that the vestibular system alone is able to indicate to subjects their position in space. The subject will be required to detect oscillatory movement, and then to distinguish between a vestibular stimulus and a pulsed auditory stimulus.

The study hypothesis is that the movement stimulation generated by our prototype will be sufficient to stimulate the vestibular system, which will manifest itself as a conscious sensation of movement and by a vestibulo-ocular reflex causing oculomotor manifestations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 21, 2017
• Est. primary completion date: April 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Older than 18 years

• National health insurance cover

• Written consent

• Subjects able to understand simple instructions and packaging information and to provide informed consent

Exclusion Criteria:

• Vertigo, consciousness disorders, nausea or pain before the tests

• Bilateral deafness

• History of neurological, rheumatic or orthopaedic disease likely by itself to trigger a fall

• Psychiatric disorder likely to compromise participation.

• Personal history of falls of undetermined cause.

• Présence de saccades et/ou nystagmus en position statique

• Femme enceinte

Related Conditions & MeSH terms

• Vestibular Stimulation

Intervention

Other:
• posturography

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cinematics of eye movements (amplitude and direction) evaluated by videonystagmography (VNG).		At Day 0