Idiopathic Bilateral Vestibulopathy: Peripheral Vestibular Disorders and Their Repercussions
NCT ID: NCT06476587
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
69 participants
OBSERVATIONAL
2022-10-05
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Integrative Study of Vestibular Pathology
NCT05525728
2BALANCE: Cognitive-motor Dual-tasking in Persons with Vestibular Disorders
NCT04126798
Vestibular and Multisensory Influence on Bodily and Spatial Representations. Behavioral and Electrophysiological Investigations in Vestibular-defective Patients and Healthy Volunteers
NCT01900457
Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.
NCT03171181
Eye Movements and Visuo-spatial Perception
NCT03112408
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IBV patients
Persons with bilateral vestibulopathy
Assessment of postural stability and active motion perception
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 tests
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 rotation
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.
Osteodensitometry
To assess the participants' bone mineral density, the reference technique of densitometry using two-photon absorptiometry will be used.
Posturography
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 test
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 assessment
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 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.
Influence of vestibular information on the bodily self-consciousness
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 MRI
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.
Controls
Healthy volunteers matched with patients with respect to their age, sex and level of education
Assessment of postural stability and active motion perception
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.
Eccentric axis rotation
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.
Posturography
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.
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.
3 Tesla MRI
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Assessment of postural stability and active motion perception
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 tests
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 rotation
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.
Osteodensitometry
To assess the participants' bone mineral density, the reference technique of densitometry using two-photon absorptiometry will be used.
Posturography
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 test
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 assessment
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 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.
Influence of vestibular information on the bodily self-consciousness
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 MRI
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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,
* Adults under legal protection or unable to express their consent,
* Persons in emergency situations who are unable to give their prior consent.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Caen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pierre DENISE, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
UMRs 1075 COMETE Unicaen / INSERM
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UMRs 1075 COMETE Unicaen INSERM
Caen, Calvados, France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-A01513-40
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.