Idiopathic Bilateral VestibulopathyVBINCT06476587
Idiopathic Bilateral Vestibulopathy: Peripheral Vestibular Disorders and Their Repercussions
An observational study of Idiopathic Bilateral Vestibulopathy, run by University Hospital, Caen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Bilateral Vestibulopathy
- What is being tested?
- Assessment of postural stability and active motion perception, Cognitive tests and Eccentric axis rotation
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2022to 31 Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants in the patient group are member of the French Association of the Idiopathic Bilateral Vestibulopathy (AFVBI) or carry a bilateral vestibulopathy
Who may be able to join
- 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
Who cannot join
- 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
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- 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,
- Adults under legal protection or unable to express their consent,
- Persons in emergency situations who are unable to give their prior consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vestibulopathie bilatérale Idiopathique : caractérisation Des Atteintes Vestibulaires périphériques et de Leurs Retentissements Posturaux, végétatifs, émotionnels et Cognitifs
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).
Read the detailed description
Bilateral vestibulopathy (BV) is defined as total or partial impairment of vestibular function on both sides, leading to chronic postural and visual instability. Idiopathic bilateral vestibulopathy (IBV) is a rare condition characterised by acquired BV of unknown aetiology. Although described more than thirty years ago, IBV remains a condition with imperfectly understood contours, mechanisms and consequences.
The peripheral vestibular system, located in the inner ear, is the main balance organ. Sensory information from the vestibular system is distributed to different brain structures, which perform a wide range of functions, such as maintaining stability of gaze and posture, controlling certain functions such as sleep, spatial memory and emotional processes, and perceiving movement, spatial orientation and self-image.
The most common symptoms of IBV are persistent postural instability, and, when moving the head and body, a reduction in visual acuity that can go as far as a sensation of instability of the visual environment. Patients also often report problems with orientation and spatial memory, poor body shape, sleep disorders, attentional problems, and anxiety or depression. Because little is known about this disease, diagnosis often comes late, after several years of various explorations and consultations with doctors and specialists.
Based on the observation that patients suffering from IBV have heterogeneous peripheral impairments, both qualitatively (type of sensory organ affected) and quantitatively (the impairment is more or less complete), and that the sometimes complex symptomatology is difficult to relate to the type of peripheral deficit, the aim of this project is to gain a better understanding of the symptomatology of IBV by evaluating certain functions that have recently been shown to be influenced by the vestibular system, and to relate this to the type and intensity of the peripheral deficit.
Hence, the main aim of this project is to study the link between symptomatology - both 'classic' (posturo-oculomotor) and cognitive, emotional and vegetative - and the type and intensity of vestibular disorder.
- Conditions
- Idiopathic Bilateral Vestibulopathy
- Being tested
- Assessment of postural stability and active motion perception, Cognitive tests, Eccentric axis rotation, Osteodensitometry, Posturography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of postural stability and active motion perceptionOther
This assessment, designed to evaluate the impact of the vestibular deficit on everyday tasks, will include questionnaires and standardised clinical tests.
The questionnaires are the Fall Efficacy Scale; the Dizziness Handicap Inventory; the Oscillopsia Severity Questionnaire; the Hospital Anxiety and Depression Scale; the Hamilton Anxiety Scale; the Global Physical Activity Questionnaire; the Motion Sickness Susceptibility Questionnaire part B; and the Cambridge Depersonalization Scale.
In addition, three standardised clinical tests will be carried out: Five Times Sit to Stand Test; Tandem walking test; and Fukuda step test (50 steps).
Five specific clinical tests will also be carried out: Sit-to-stand-with-walk-and-turn; Perception of active body rotation; Perception of walking distance; Triangle Completion Task; and Gait assessment.
Cognitive testsOther
Four cognitive tests from the French Focus Group on Executive Functions Assessment (GREFEX) battery will be carried out: the Stroop test; the Trail Making Test; the Baddeley's dual task; and a test of Corsi's Blocks.
Eccentric axis rotationOther
This test, also known as the unilateral centrifugation test, provides a quantitative assessment of unilateral utricular otolith function, whereas the tests currently used (vestibular evoked myogenic potential, VEMP) only provide a qualitative assessment.
OsteodensitometryOther
To assess the participants' bone mineral density, the reference technique of densitometry using two-photon absorptiometry will be used.
PosturographyOther
Participants' ability to maintain their balance will be assessed using measurements taken on the Synapsys platform. To standardise their position, they will have to stand on the platform with their feet apart, arms at their sides and look straight ahead. Volunteers will be asked to sit down between each trial. The surface area and length of the centre of pressure will be measured under open-eye balance conditions with and without image reading/exploration and dynamics. During this test, 9 balance assessment situations lasting approximately 1 minute each will be performed.
Vestibulo-sympathetic regulation testOther
Participants will be seated on a rotating chair in the dark. Using a virtual reality headset, three visual stimuli will be presented: (A) no visual stimulus (darkness), (B) visual stimulus corresponding to a displacement of the participant along a cylindrical trajectory, (C) visual stimulus corresponding to a displacement of the participant along a conical trajectory. These 3 types of visual stimuli will be presented alone or during an Off-Vertical Axis Rotation (OVAR) with the chair axis inclined at an angle of 10° to the vertical and a rotation speed of 60°/s.
During each sequence, blood pressure, heart rate and end-tidal carbon dioxide (CO2) will be continuously recorded using standard medical equipment.
Sleep quality assessmentOther
Participants will have to complete five standardised clinical questionnaires: Pittsburgh Sleep Quality Index; Spiegel questionnaire assessing sleep quality; Morningness-Eveningness questionnaire; Insomnia Severity Scale; and Epworth Sleepiness Scale.
Moreover, the activity/rest rhythm will be measured continuously by actimetry over a period of 11 days.
The volunteer will also have to wear a Somno-Art® bracelet all night long during the eleven days of monitoring to collect the volunteer's actimetry and heart rate in order to specify which sleep stage the volunteer is in and thus monitor changes in sleep stages over the course of the night.
Finally, participants will have to complete a sleep diary.
Representation of space and time assessmentOther
- Classic geometric illusions (inverted T, Mueller-Lyer, Ponzo, Poggendorff, Zoellner, Hering) which generate systematic distortions will be used.
- Time perception task: Participants will wear a virtual reality headset in which instructions will appear for 6 consecutive tasks each repeated 10 times with different durations.
- Perception of rotation amplitude and duration: Participants will be seated on a rotating chair, in complete darkness with noise-cancelling headphones. Participant will have to estimate the duration and the amplitude of rotations of the chair.
- Perceptual time constant: Participants will be seated on a rotating chair, in complete darkness, with a mask over their eyes and noise-cancelling headphones. After each chair rotation, participants will have to turn a crank every time the chair stops and reproduce their sensation of rotation in terms of direction (left or right) and intensity.
Influence of vestibular information on the bodily self-consciousnessOther
Participants will wear a virtual reality headset which allows them to be immersed in a virtual room similar in appearance to the one they are in. They will sit on a stool and hold a joystick in their hand. An avatar seen from behind, also sitting on a stool, will be presented in the centre of the virtual room approximately 2 m from them. The experimenter will touch several areas of the participant's back, over his clothes, with the end of the joystick. This movement will be reproduced by the virtual joystick in contact with the avatar's back, in two conditions: the synchronous condition, and the asynchronous condition.
After 2 min of stimulation, participants will perform a mental imagery task: a ball in the background of the virtual scene will roll towards them. After 3'', a black screen will appear and participants will have to imagine that the ball keeps moving towards them at the same speed. They will have to press the trigger when they think the ball has reached their level.
3 Tesla MRIOther
The imaging evaluation will include an acquisition of anatomical images of the brain in its entirety and centred on the hippocampus.; and T2*-weighted images sensitive to the blood-oxygen-level-dependent (BOLD) effect to assess functional brain activation during cognitive tasks and functional brain connectivity during rest.
For the functional activation sequences, three activation tasks will be performed, each lasting approximately 5 minutes: a mental rotation task, a time estimation task, and a prediction task.
These acquisitions will be combined with a collection of cardiorespiratory variables: respiratory movements and plethysmography. These signals will be used in the pre-processing of the functional MRI to remove physiological noise from the BOLD signal.
| Study group | Role | What they receive |
|---|---|---|
| IBV patients | Persons with bilateral vestibulopathy Receives: Other: Assessment of postural stability and active motion perception; Other: Cognitive tests; Other: Eccentric axis rotation; Other: Osteodensitometry; Other: Posturography; Other: Vestibulo-sympathetic regulation test; Other: Sleep quality assessment; Other: Representation of space and time assessment; Other: Influence of vestibular information on the bodily self-consciousness; Other: 3 Tesla MRI | |
| Controls | Healthy volunteers matched with patients with respect to their age, sex and level of education Receives: Other: Assessment of postural stability and active motion perception; Other: Eccentric axis rotation; Other: Posturography; Other: Representation of space and time assessment; Other: 3 Tesla MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of pressure (CoP) path length
Stabilometric data: Total length travelled by the CoP (in mm)
Measured: Posturography is assessed once, during about 30 minutes.
Center of pressure (CoP) path amplitude
Stabilometric data: Maximal distance over two points of the stabilogram (in mm)
Measured: Posturography is assessed once, during about 30 minutes.
Center of pressure (CoP) surface area
Stabilometric data: surface travelled by the CoP (in mm²)
Measured: Posturography is assessed once, during about 30 minutes.
Ocular torsion
During eccentric axis rotation: measure of the torsion of the eyes (in degree)
Measured: Unilateral utricular otolith function is assessed once, during about 30 minutes
Duration estimate
During the time perception task, subjects are asked to estimate several durations (in seconds).
Measured: Time perception task is completed once, during about 30 minutes.
Duration production
During the time perception task, subjects are asked to produce several durations (in seconds).
Measured: Time perception task is completed once, during about 30 minutes.
Number of correct tandem steps
During tandem stance and walk, subjects are asked to stand upright in a heel-to-toe fashion with their arms crossed on their chest and walk.
Measured: Assessment of postural stability and active motion perception is completed once, during about 30 minutes
Deviation distance (Fukuda stepping test)
During the Fukuda stepping test, subjects are asked to take 50 steps on the spot, on a mat, with their eyes closed and their arms outstretched in front of them. Deviation distance is measured in cm.
Measured: Assessment of postural stability and active motion perception is completed once, during about 30 minutes
Deviation angle (Fukuda stepping test)
During the Fukuda stepping test, subjects are asked to take 50 steps on the spot, on a mat, with their eyes closed and their arms outstretched in front of them. Deviation angle is measured in degrees.
Measured: Assessment of postural stability and active motion perception is completed once, during about 30 minutes
Hippocampal volume
Images of hippocampus are acquired by MRI
Measured: MRI exam is completed once, during about 1 hour
Brain activation during functional tasks
Images of the brain when participants are performing cognitive tasks (mental rotation task, prediction task) are acquired by functional magnetic resonance imaging (fMRI)
Measured: MRI exam is completed once, during about 1 hour
Secondary outcomes (14)
Center of pressure (CoP) standard deviation - Anteroposterior
Stabilometric data: Standard deviation of the CoP position in the anteroposterior axis (in mm)
Measured: Posturography is assessed once, during about 30 minutes.
Center of pressure (CoP) standard deviation - Mediolateral
Stabilometric data: Standard deviation of the CoP position in the mediolateral axis (in mm)
Measured: Posturography is assessed once, during about 30 minutes.
Duration of the word reading in the congruent condition
Stroop color and word test : time spent to read the words in the congruent condition (in seconds)
Measured: Cognitive functions are assessed once, during about 30 minutes
Duration of the colour naming
Stroop color and word test : time spent to name the colours (in seconds)
Measured: Cognitive functions are assessed once, during about 30 minutes
Duration of the word reading in the incongruent condition
Stroop color and word test : time spent to read the words in the incongruent condition (in seconds)
Measured: Cognitive functions are assessed once, during about 30 minutes
Trail making test part A
Paper and pencil Trail Making Test: Time spent by the subject to draw a line between numbers from 1 to 25 (in seconds)
Measured: Cognitive functions are assessed once, during about 30 minutes
Trail making test part B
Paper and pencil Trail Making Test: Time spent by the subject to draw a line between numbers and letters (1-A, 2-B, etc.) (in seconds)
Measured: Cognitive functions are assessed once, during about 30 minutes
Digit span during dual-task
Number of digits correctly recalled during the Baddeley's dual-task
Measured: Cognitive functions are assessed once, during about 30 minutes
Number of sequences correctly recalled
In the simple and dual conditions of the Baddeley's dual-task
Measured: Cognitive functions are assessed once, during about 30 minutes
Spatial span
Number of blocks correctly recalled during the Corsi task
Measured: Cognitive functions are assessed once, during about 30 minutes
Estimation of the duration of rotation
During the Perception of the amplitude and duration of rotations task, subjects seated in a rotating chair are asked to estimate the duration of the rotations (in seconds)
Measured: Perception of the amplitude and duration of rotations task is completed once, during about 30 minutes.
Estimation of the amplitude of rotation
During the Perception of the amplitude and duration of rotations task, subjects seated in a rotating chair are asked to estimate the amplitude of the rotations (in degree)
Measured: Perception of the amplitude and duration of rotations task is completed once, during about 30 minutes.
Deviation distance (Triangle completion task)
During the triangle completion task, the participant will wear a blindfold and a noise-cancelling headphones. Guided by the experimenter, who will hold them by the shoulders, they will walk along the first two sides of a triangle. The participant will then have to turn on their own and walk along the third side to get back to the starting point. The deviation distance is measured in cm.
Measured: Assessment of postural stability and active motion perception is completed once, during about 30 minutes
Deviation angle (Triangle completion task)
During the triangle completion task, the participant will wear a blindfold and a noise-cancelling headphones. Guided by the experimenter, who will hold them by the shoulders, they will walk along the first two sides of a triangle. The participant will then have to turn on their own and walk along the third side to get back to the starting point. The deviation angle is measured in degree.
Measured: Assessment of postural stability and active motion perception is completed once, during about 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start5 Oct 2022
- Primary completion15 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Bilateral VestibulopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre DENISE, MD-PhD, Principal investigator, UMRs 1075 COMETE Unicaen / INSERM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476587
- Sponsor's protocol ID
- 2022-A01513-40
- Acronym
- VBI
- Status last verified
- Jul 2025
- First submitted
- 22 May 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibulopathie bilatérale Idiopathique : caractérisation Des Atteintes Vestibulaires périphériques et de Leurs Retentissements Posturaux, végétatifs, émotionnels et Cognitifs
- ClinicalTrials.gov ID
- NCT06476587
- Acronym / sponsor ID
- VBI / 2022-A01513-40
- Conditions
- Idiopathic Bilateral Vestibulopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Jun 2024 (actual)
- 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 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).
Detailed description
Bilateral vestibulopathy (BV) is defined as total or partial impairment of vestibular function on both sides, leading to chronic postural and visual instability. Idiopathic bilateral vestibulopathy (IBV) is a rare condition characterised by acquired BV of unknown aetiology. Although described more than thirty years ago, IBV remains a condition with imperfectly understood contours, mechanisms and consequences.
The peripheral vestibular system, located in the inner ear, is the main balance organ. Sensory information from the vestibular system is distributed to different brain structures, which perform a wide range of functions, such as maintaining stability of gaze and posture, controlling certain functions such as sleep, spatial memory and emotional processes, and perceiving movement, spatial orientation and self-image.
The most common symptoms of IBV are persistent postural instability, and, when moving the head and body, a reduction in visual acuity that can go as far as a sensation of instability of the visual environment. Patients also often report problems with orientation and spatial memory, poor body shape, sleep disorders, attentional problems, and anxiety or depression. Because little is known about this disease, diagnosis often comes late, after several years of various explorations and consultations with doctors and specialists.
Based on the observation that patients suffering from IBV have heterogeneous peripheral impairments, both qualitatively (type of sensory organ affected) and quantitatively (the impairment is more or less complete), and that the sometimes complex symptomatology is difficult to relate to the type of peripheral deficit, the aim of this project is to gain a better understanding of the symptomatology of IBV by evaluating certain functions that have recently been shown to be influenced by the vestibular system, and to relate this to the type and intensity of the peripheral deficit.
Hence, the main aim of this project is to study the link between symptomatology - both 'classic' (posturo-oculomotor) and cognitive, emotional and vegetative - and the type and intensity of vestibular disorder.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBV patients | – | Other: Assessment of postural stability and active motion perception, Other: Cognitive tests, Other: Eccentric axis rotation, Other: Osteodensitometry, Other: Posturography, Other: Vestibulo-sympathetic regulation test, Other: Sleep quality assessment, Other: Representation of space and time assessment, Other: Influence of vestibular information on the bodily self-consciousness, Other: 3 Tesla MRIPersons with bilateral vestibulopathy |
| Controls | – | Other: Assessment of postural stability and active motion perception, Other: Eccentric axis rotation, Other: Posturography, Other: Representation of space and time assessment, Other: 3 Tesla MRIHealthy volunteers matched with patients with respect to their age, sex and level of education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in the patient group are member of the French Association of the Idiopathic Bilateral Vestibulopathy (AFVBI) or carry a bilateral vestibulopathy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
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 |
|---|---|---|
| Assessment of postural stability and active motion perceptionThis assessment, designed to evaluate the impact of the vestibular deficit on everyday tasks, will include questionnaires and standardised clinical tests. The questionnaires are the Fall Efficacy Scale; the Dizziness Handicap Inventory; the Oscillopsia Severity Questionnaire; the Hospital Anxiety and Depression Scale; the Hamilton Anxiety Scale; the Global Physical Activity Questionnaire; the Motion Sickness Susceptibility Questionnaire part B; and the Cambridge Depersonalization Scale. In addition, three standardised clinical tests will be carried out: Five Times Sit to Stand Test; Tandem walking test; and Fukuda step test (50 steps). Five specific clinical tests will also be carried out: Sit-to-stand-with-walk-and-turn; Perception of active body rotation; Perception of walking distance; Triangle Completion Task; and Gait assessment. | Other | Controls, IBV patients |
| Cognitive testsFour cognitive tests from the French Focus Group on Executive Functions Assessment (GREFEX) battery will be carried out: the Stroop test; the Trail Making Test; the Baddeley's dual task; and a test of Corsi's Blocks. | Other | IBV patients |
| Eccentric axis rotationThis test, also known as the unilateral centrifugation test, provides a quantitative assessment of unilateral utricular otolith function, whereas the tests currently used (vestibular evoked myogenic potential, VEMP) only provide a qualitative assessment. | Other | Controls, IBV patients |
| OsteodensitometryTo assess the participants' bone mineral density, the reference technique of densitometry using two-photon absorptiometry will be used. | Other | IBV patients |
| PosturographyParticipants' ability to maintain their balance will be assessed using measurements taken on the Synapsys platform. To standardise their position, they will have to stand on the platform with their feet apart, arms at their sides and look straight ahead. Volunteers will be asked to sit down between each trial. The surface area and length of the centre of pressure will be measured under open-eye balance conditions with and without image reading/exploration and dynamics. During this test, 9 balance assessment situations lasting approximately 1 minute each will be performed. | Other | Controls, IBV patients |
| Vestibulo-sympathetic regulation testParticipants will be seated on a rotating chair in the dark. Using a virtual reality headset, three visual stimuli will be presented: (A) no visual stimulus (darkness), (B) visual stimulus corresponding to a displacement of the participant along a cylindrical trajectory, (C) visual stimulus corresponding to a displacement of the participant along a conical trajectory. These 3 types of visual stimuli will be presented alone or during an Off-Vertical Axis Rotation (OVAR) with the chair axis inclined at an angle of 10° to the vertical and a rotation speed of 60°/s. During each sequence, blood pressure, heart rate and end-tidal carbon dioxide (CO2) will be continuously recorded using standard medical equipment. | Other | IBV patients |
| Sleep quality assessmentParticipants will have to complete five standardised clinical questionnaires: Pittsburgh Sleep Quality Index; Spiegel questionnaire assessing sleep quality; Morningness-Eveningness questionnaire; Insomnia Severity Scale; and Epworth Sleepiness Scale. Moreover, the activity/rest rhythm will be measured continuously by actimetry over a period of 11 days. The volunteer will also have to wear a Somno-Art® bracelet all night long during the eleven days of monitoring to collect the volunteer's actimetry and heart rate in order to specify which sleep stage the volunteer is in and thus monitor changes in sleep stages over the course of the night. Finally, participants will have to complete a sleep diary. | Other | IBV patients |
| Representation of space and time assessment* Classic geometric illusions (inverted T, Mueller-Lyer, Ponzo, Poggendorff, Zoellner, Hering) which generate systematic distortions will be used. * Time perception task: Participants will wear a virtual reality headset in which instructions will appear for 6 consecutive tasks each repeated 10 times with different durations. * Perception of rotation amplitude and duration: Participants will be seated on a rotating chair, in complete darkness with noise-cancelling headphones. Participant will have to estimate the duration and the amplitude of rotations of the chair. * Perceptual time constant: Participants will be seated on a rotating chair, in complete darkness, with a mask over their eyes and noise-cancelling headphones. After each chair rotation, participants will have to turn a crank every time the chair stops and reproduce their sensation of rotation in terms of direction (left or right) and intensity. | Other | Controls, IBV patients |
| Influence of vestibular information on the bodily self-consciousnessParticipants will wear a virtual reality headset which allows them to be immersed in a virtual room similar in appearance to the one they are in. They will sit on a stool and hold a joystick in their hand. An avatar seen from behind, also sitting on a stool, will be presented in the centre of the virtual room approximately 2 m from them. The experimenter will touch several areas of the participant's back, over his clothes, with the end of the joystick. This movement will be reproduced by the virtual joystick in contact with the avatar's back, in two conditions: the synchronous condition, and the asynchronous condition. After 2 min of stimulation, participants will perform a mental imagery task: a ball in the background of the virtual scene will roll towards them. After 3'', a black screen will appear and participants will have to imagine that the ball keeps moving towards them at the same speed. They will have to press the trigger when they think the ball has reached their level. | Other | IBV patients |
| 3 Tesla MRIThe imaging evaluation will include an acquisition of anatomical images of the brain in its entirety and centred on the hippocampus.; and T2*-weighted images sensitive to the blood-oxygen-level-dependent (BOLD) effect to assess functional brain activation during cognitive tasks and functional brain connectivity during rest. For the functional activation sequences, three activation tasks will be performed, each lasting approximately 5 minutes: a mental rotation task, a time estimation task, and a prediction task. These acquisitions will be combined with a collection of cardiorespiratory variables: respiratory movements and plethysmography. These signals will be used in the pre-processing of the functional MRI to remove physiological noise from the BOLD signal. | Other | Controls, IBV patients |
Primary outcome
Center of pressure (CoP) path length
Time frame: Posturography is assessed once, during about 30 minutes.
Stabilometric data: Total length travelled by the CoP (in mm)
Center of pressure (CoP) path amplitude
Time frame: Posturography is assessed once, during about 30 minutes.
Stabilometric data: Maximal distance over two points of the stabilogram (in mm)
Center of pressure (CoP) surface area
Time frame: Posturography is assessed once, during about 30 minutes.
Stabilometric data: surface travelled by the CoP (in mm²)
Ocular torsion
Time frame: Unilateral utricular otolith function is assessed once, during about 30 minutes
During eccentric axis rotation: measure of the torsion of the eyes (in degree)
Duration estimate
Time frame: Time perception task is completed once, during about 30 minutes.
During the time perception task, subjects are asked to estimate several durations (in seconds).
Duration production
Time frame: Time perception task is completed once, during about 30 minutes.
During the time perception task, subjects are asked to produce several durations (in seconds).
Number of correct tandem steps
Time frame: Assessment of postural stability and active motion perception is completed once, during about 30 minutes
During tandem stance and walk, subjects are asked to stand upright in a heel-to-toe fashion with their arms crossed on their chest and walk.
Deviation distance (Fukuda stepping test)
Time frame: Assessment of postural stability and active motion perception is completed once, during about 30 minutes
During the Fukuda stepping test, subjects are asked to take 50 steps on the spot, on a mat, with their eyes closed and their arms outstretched in front of them. Deviation distance is measured in cm.
Deviation angle (Fukuda stepping test)
Time frame: Assessment of postural stability and active motion perception is completed once, during about 30 minutes
During the Fukuda stepping test, subjects are asked to take 50 steps on the spot, on a mat, with their eyes closed and their arms outstretched in front of them. Deviation angle is measured in degrees.
Hippocampal volume
Time frame: MRI exam is completed once, during about 1 hour
Images of hippocampus are acquired by MRI
Brain activation during functional tasks
Time frame: MRI exam is completed once, during about 1 hour
Images of the brain when participants are performing cognitive tasks (mental rotation task, prediction task) are acquired by functional magnetic resonance imaging (fMRI)
14 secondary outcomes
Center of pressure (CoP) standard deviation - Anteroposterior
Time frame: Posturography is assessed once, during about 30 minutes.
Center of pressure (CoP) standard deviation - Mediolateral
Time frame: Posturography is assessed once, during about 30 minutes.
Duration of the word reading in the congruent condition
Time frame: Cognitive functions are assessed once, during about 30 minutes
Duration of the colour naming
Time frame: Cognitive functions are assessed once, during about 30 minutes
Duration of the word reading in the incongruent condition
Time frame: Cognitive functions are assessed once, during about 30 minutes
Trail making test part A
Time frame: Cognitive functions are assessed once, during about 30 minutes
Trail making test part B
Time frame: Cognitive functions are assessed once, during about 30 minutes
Digit span during dual-task
Time frame: Cognitive functions are assessed once, during about 30 minutes
Number of sequences correctly recalled
Time frame: Cognitive functions are assessed once, during about 30 minutes
Spatial span
Time frame: Cognitive functions are assessed once, during about 30 minutes
Estimation of the duration of rotation
Time frame: Perception of the amplitude and duration of rotations task is completed once, during about 30 minutes.
Estimation of the amplitude of rotation
Time frame: Perception of the amplitude and duration of rotations task is completed once, during about 30 minutes.
Deviation distance (Triangle completion task)
Time frame: Assessment of postural stability and active motion perception is completed once, during about 30 minutes
Deviation angle (Triangle completion task)
Time frame: Assessment of postural stability and active motion perception is completed once, during about 30 minutes
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 25 Jul 2025.
- Individual participant dataSharing planned: No
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.
Pierre DENISE, MD-PhD principal investigator
UMRs 1075 COMETE Unicaen / INSERM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Bilateral Vestibulopathy, run by University Hospital, Caen 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 4 inclusion and 14 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 25 Jul 2025. 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?
Center of pressure (CoP) path length (time frame: Posturography is assessed once, during about 30 minutes.). The study lists 11 primary outcomes in all. 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 25 Jul 2025.