CompletedNot Applicable

Idiopathic Bilateral Vestibulopathy: Peripheral Vestibular Disorders and Their Repercussions

France69 participantsStarted 2022-10-05

Plain-language summary

The goal of this exploratory study is to gain a better understanding of the symptomatology of idiopathic bilateral vestibulopathy (IBV) by characterising as precisely as possible the type and intensity of each patient's peripheral vestibular deficit, and to investigate the link between this symptomatology and some functions influenced by the vestibular system (i.e. cognitive, emotional, vegetative functions).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Person over 18 years of age (male or female) * Healthy volunteer (for participants in the control group) or a member of the French Association of the Idiopathic Bilateral Vestibulopathy (AFVBI) or a bilateral vestibulopathy carrier (for participants in the patient group). * Person who has read the information sheet and given written informed consent to take part in the study. * Person affiliated to a social security scheme Exclusion Criteria: * Declaration of illiteracy * Declaration of dementia (Alzheimer's disease, vascular dementia) * Any progressive neurological disease (brain tumour, epilepsy, migraine, stroke, sclerosis, myoclonus, chorea, neuropathy, muscular dystrophy, myotonic dystrophy, etc.) * All progressive psychiatric conditions (psychosis, mood or anxiety disorders, etc.), * Declaration of pathologies threatening short-term vital prognosis (cancer) * Drug addiction, alcohol dependence or coffee abuse during the last 6 months * Contraindications to MRI (in particular electronic or metallic implants, claustrophobia, etc.). * For healthy volunteers: vestibular or auditory disorders. In addition, the vulnerable persons referred to in articles L. 1121-5 to 8 and L. 1122-1-2 of the French Public Health Code are excluded from the study: * Pregnant, breast-feeding or parturient women, * Persons deprived of their liberty, hospitalised without consent or admitted to a health or social establishment for purposes other than research, * Minors, * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Center of pressure (CoP) path length

Timeframe: Posturography is assessed once, during about 30 minutes.

Center of pressure (CoP) path amplitude

Timeframe: Posturography is assessed once, during about 30 minutes.

Center of pressure (CoP) surface area

Timeframe: Posturography is assessed once, during about 30 minutes.

Ocular torsion

Timeframe: Unilateral utricular otolith function is assessed once, during about 30 minutes

Duration estimate

Timeframe: Time perception task is completed once, during about 30 minutes.

Duration production

Timeframe: Time perception task is completed once, during about 30 minutes.

Number of correct tandem steps

Timeframe: Assessment of postural stability and active motion perception is completed once, during about 30 minutes

Trial details

NCT IDNCT06476587

SponsorUniversity Hospital, Caen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-15

View on ClinicalTrials.gov More Idiopathic Bilateral Vestibulopathy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Center of pressure (CoP) path length

Timeframe: Posturography is assessed once, during about 30 minutes.

Center of pressure (CoP) path amplitude

Timeframe: Posturography is assessed once, during about 30 minutes.

Center of pressure (CoP) surface area

Timeframe: Posturography is assessed once, during about 30 minutes.

Ocular torsion

Timeframe: Unilateral utricular otolith function is assessed once, during about 30 minutes

Duration estimate

Timeframe: Time perception task is completed once, during about 30 minutes.

Duration production

Timeframe: Time perception task is completed once, during about 30 minutes.

Number of correct tandem steps

Timeframe: Assessment of postural stability and active motion perception is completed once, during about 30 minutes