跳至主要内容
临床试验/NCT02463695
NCT02463695Unknown不适用

Characterisation of Cortical Vestibular Evoked Potentials (C-VEPs): A Comparative Study of Normal Ears Versus Those With Vestibular Deficits

Sheffield Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
51
试验地点
1
主要终点
The degree of change of cortical vestibular evoked potential measured by amplitude (in microvolts)

研究概览

简要总结

The pathophysiology of vertigo is complex and usually requires specialist involvement. During the diagnostic process, patients commonly undergo tests which assess the integrity of the gaze and posture stabilisation mechanisms involving the inner ear (vestibular system), the visual systems and the subconscious neural pathways that interconnect them. Whilst these tests are useful they fail to provide information concerning the neural connections to the cortex and therefore neglect the perceptual aspects of disequilibrium.

At present the possibility of routine examination of these higher projections remains elusive as no practical alternatives to the expensive functional magnetic resonance imaging systems exist. However, recently a novel method of recording cortical vestibular evoked potentials (CVEPs) has been described.

CVEPs utilise an existing method used to interrogate cortical projections from the auditory system in which sound waves stimulate the inner ear and the resulting electrical responses from the brain are recorded. The recent breakthrough is in the realisation that these responses also contain information from the balance organs and therefore are a direct measure of cortical processing of the vestibular inputs.

Current evidence shows that CVEPs are present in the normal population and absent in patients with no vestibular function. The primary aim for this study is to extend the patient cohort to include those who have a vestibular injury but retain residual function. Patients going through standard testing will have also have CVEPs on both ears providing seminal information into the effect of injury to the peripheral vestibular system on the cortical pathways. Furthermore, by following the cohort through their complete management pathway it will be possible to ascertain if the CVEP can be used to predict rehabilitation outcome success.

详细描述

Ears with a vestibular deficit:

Patients referred to the tertiary ear nose and throat clinics as well otoneurological clinics at the Royal Hallamshire will be eligible for enrolment. The investigators aim to record data from 36 ears with vestibular dysfunction.

A) Patients will receive a consultation with an ENT Consultant or Registrar as per standard practice.

B) If the patient is deemed by the doctor to have an otoneurological cause for their symptoms then further audiovestibular testing and imaging will be arranged as per standard practice. The patients will then be made aware of this study and if interested will be given the opportunity to discuss it further with the chief investigator (CI) or the principal investigator (PI).

C) If agreeable the patients will be given information packs by the PI/CI and taken through the study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • •Vestibular deficit Group:
  • •Over 18 years of age
  • •Can provide informed consent
  • •Deemed to have an otoneurological cause for their symptoms (true vertigo, room spinning even when head is still)
  • •No middle ear pathology
  • •NORMATIVE GROUP:
  • •Over 18 years of age
  • •Can provide informed consent
  • •No previous otoneurological history

排除标准

  • •VESTIBULAR DEFICIT GROUP PATIENTS
  • •Participants under the age of 18
  • •Participants unable to provide informed consent
  • •Patients not deemed to have an otoneurological cause for their symptoms
  • •Patients with middle ear pathology
  • •NORMATIVE GROUP:
  • •Previous history of problems with hearing and or balance
  • •Participants under the age of 18
  • •Participants unable to provide informed consent

研究组 & 干预措施

vestibular deficit

Experimental
  • Initial clinical assessment including otoneurological examination, pure tone audiometry, tympanometry vestibular screening tests and Magnetic Resonance Imaging as clinically indicated.
  • The cortical vestibular evoked potentials will add approximately add an extra 30 minutes to the test sequence but is minimally invasive and will not cause any pain or discomfort. It will be conducted on both the affected and non-affected ears.

干预措施: cortical vestibular evoked potentials (CVEPs) (Procedure)

otologically normal controll

Active Comparator

Normative data will be collected from 36 normal ears from subjects that have no history of audiovestibular symptoms and are not being investigated for any balance disorders. The cortical vestibular evoked potentials will be recorded from both ears

干预措施: cortical vestibular evoked potentials (CVEPs) (Procedure)

结局指标

主要结局

The degree of change of cortical vestibular evoked potential measured by amplitude (in microvolts)

时间窗: 6 months

次要结局

  • The time interval between the stimulation and response (latency) of cortical vestibular evoked potential(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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