Vestibulopathie bilatérale Idiopathique : caractérisation Des Atteintes Vestibulaires périphériques et de Leurs Retentissements Posturaux, végétatifs, émotionnels et Cognitifs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Hippocampal volume
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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,
- •Adults under legal protection or unable to express their consent,
- •Persons in emergency situations who are unable to give their prior consent.
结局指标
主要结局
Hippocampal volume
时间窗: MRI exam is completed once, during about 1 hour
Images of hippocampus are acquired by MRI
Ocular torsion
时间窗: Unilateral utricular otolith function is assessed once, during about 30 minutes
During eccentric axis rotation: measure of the torsion of the eyes (in degree)
Number of correct tandem steps
时间窗: 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 angle (Fukuda stepping test)
时间窗: 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.
Center of pressure (CoP) path amplitude
时间窗: 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
时间窗: Posturography is assessed once, during about 30 minutes.
Stabilometric data: surface travelled by the CoP (in mm²)
Duration estimate
时间窗: 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
时间窗: Time perception task is completed once, during about 30 minutes.
During the time perception task, subjects are asked to produce several durations (in seconds).
Deviation distance (Fukuda stepping test)
时间窗: 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.
Brain activation during functional tasks
时间窗: 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)
Center of pressure (CoP) path length
时间窗: Posturography is assessed once, during about 30 minutes.
Stabilometric data: Total length travelled by the CoP (in mm)
次要结局
- Center of pressure (CoP) standard deviation - Mediolateral(Posturography is assessed once, during about 30 minutes.)
- Duration of the word reading in the congruent condition(Cognitive functions are assessed once, during about 30 minutes)
- Center of pressure (CoP) standard deviation - Anteroposterior(Posturography is assessed once, during about 30 minutes.)
- Duration of the colour naming(Cognitive functions are assessed once, during about 30 minutes)
- Trail making test part B(Cognitive functions are assessed once, during about 30 minutes)
- Duration of the word reading in the incongruent condition(Cognitive functions are assessed once, during about 30 minutes)
- Trail making test part A(Cognitive functions are assessed once, during about 30 minutes)
- Digit span during dual-task(Cognitive functions are assessed once, during about 30 minutes)
- Number of sequences correctly recalled(Cognitive functions are assessed once, during about 30 minutes)
- Spatial span(Cognitive functions are assessed once, during about 30 minutes)
- Estimation of the duration of rotation(Perception of the amplitude and duration of rotations task is completed once, during about 30 minutes.)
- Estimation of the amplitude of rotation(Perception of the amplitude and duration of rotations task is completed once, during about 30 minutes.)
- Deviation distance (Triangle completion task)(Assessment of postural stability and active motion perception is completed once, during about 30 minutes)
- Deviation angle (Triangle completion task)(Assessment of postural stability and active motion perception is completed once, during about 30 minutes)