Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Width of conductance tympanograms at 2 kHz measurement
研究概览
简要总结
The aim of this study is to compare the value of multifrequency tympanometry between patients with surgical indication of treatment for a Chiari type I malformation and healthy volunteers.
详细描述
Prevalence of Chiari type I malformation in population is between 0.1% and 0.5%. Chiari type I malformation is responsive in perturbation of the cerebro spinal fluid flow at the cranio-cervical junction. Those perturbations caused headaches, and various otological symptoms (dizziness, tinnitus, vertigo, nystagmus, hypoacousis…). The surgical treatment consists in an occipital craniotomy to restore the cerebro spinal fluid flow at the cranio-cervical junction. Symptoms are due to increasing of the pressure in the cerebellar fossa. 81% of the patients with Chiari type 1 malformation suffer of sub clinical otological perturbations especially alteration of the vestibular test.
In the literature, hearing performance could be normalized after posterior fossa decompression. Furthermore, the multifrequency tympanometry measurement and particularly the width of conductance tympanograms at 2 kHz shows that variations of the cerebro spinal fluid pressure have consequences on the pressure of the perilymph.
Investigator's hypothesis is that tympanometry (conductance) could be an effective test to show the variation of the cerebro spinal fluid pressure.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chiari type I malformation proved at MRI or CT-scan with an indication of cranio cervical decompression.
- •Patients between 18 and 60 years old.
- •Patient should benefit of the national health care system
- •Agreement of the patient
- •Inclusion criteria for healthy volunteers:
- •Between 18 and 60 years old.
- •Free of otologic pathology
- •Benefit of the national health care system
- •Agreement of the volunteers
排除标准
- •Acute hydrocephaly
- •Other type of Chiari disease (induced…)
- •Medical history of neurosurgery
- •Contraindication for MRI
- •Chronic otitis
- •Medical history of ontological surgery
- •Tympanic perforation
- •Disturbance of tonal audiometry with air bone more than 20dB in 4 frequencies with abolition of stapedial reflex
- •Pregnant women or nursing women
- •Protected adults by French laws
- •Exclusion criteria for healthy volunteers:
- •Medical history of neurosurgery
- •Chronic otitis
- •Medical history of ontological surgery
- •Tympanic perforation
- •Disturbance of tonal audiometry with air bone more than 20dB in 4 frequencies with abolition of stapedial reflex
- •Pregnant women or nursing women
- •Medical history of Chiari malformation
- •Chronic headaches or neck pain
- •Protected adults by French laws
结局指标
主要结局
Width of conductance tympanograms at 2 kHz measurement
时间窗: Inclusion
次要结局
- Multifrequency tympanometry(Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation)
- Cerebro spinal fluid pressure of the cranio cervical junction(Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation)
- Resonance frequency(Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation)
- Audiometric parameters(Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation)
- Otological symptoms(Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation)
- Pain measurement with Headache Impact Test(Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation)