Integrative Study of Vestibular Pathology With Analysis of Postural, Neurosensory, and Cognitive Disorders: Search for New Markers on the Causes and Consequences of Vertigo
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Sleep
研究概览
简要总结
Exploratory posturological, neurosensory, cognitive, emotional, personality and general evaluations (quality of life).
The investigators will characterize a sensory profile quantified by one or more scores from a multi-parameter baysian approach. Each parameter and these scores will be correlated to the type of vestibular damage and its recovery in order to establish diagnostic, prognostic and therapeutic follow-up markers.
详细描述
This is an exploratory neurophysiological work that aims to identify diagnostic, prognostic and therapeutic markers in vestibular pathology.
Theinvestigators wish to characterize the neurosensory profile of individuals using new exploration paradigms provided by a new posturology platform coupled with virtual reality scenarios and by proposing a complete transversal approach in terms of evaluation of the subjects: personality, cognition, emotion including the depressive state, sensory strategy, general data.
Baysian statistical approaches and linear mixed model will be used to determine markers of sensory profile correlated to the vestibular damage for diagnostic, prognostic and therapeutic follow-up.
The investigators aim to be able to better characterize the cognitive-emotional and sensory deficits expressed by the vertiginous and unstable patients, to integrate it into the evaluation of the vestibular pathology, to use these markers to better discriminate the underlying physiopathological mechanisms, and to improve at the same time the diagnosis of the functional attack and the rehabilitation follow-up of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient (18-80 years old)
- •Patient with an acute or chronic vestibular pathology according to ENT diagnostic criteria
排除标准
- •Subjects under 18 years of age
- •Pregnant or breastfeeding women,
- •Persons in an emergency situation or unable to give their consent, including adults under guardianship
- •Person under legal protection
- •Patient presenting a vertigo or postural disorders of non vestibular etiology
- •Persons deprived of liberty, minors, protected adults,
- •Patients with an intercurrent neurological pathology including cerebellar pathology
- •Inclusion of the subject in another interventional research protocol with pharmacological aim during the present study
研究组 & 干预措施
patient
One cohort of patients
干预措施: Neurosensory (Other)
结局指标
主要结局
Sleep
时间窗: through follow-up, an average of 6 months
Quantitative sleep recording
Cognition
时间窗: through follow-up, an average of 6 months
Spatial cognitive performance in a calibrated virtual radial maze
Posture
时间窗: through follow-up, an average of 6 months
postural measurement
Personnality characteristic
时间窗: through follow-up, an average of 6 months
Evaluation of the BIg Five inventory test
Emotion
时间窗: through follow-up, an average of 6 months
Anxiety measurement via questionnary
次要结局
未报告次要终点
研究者
Stéphane BESNARD
Associate professor
University Hospital, Caen