Status:
COMPLETED
Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Arnold-Chiari Malformation, Type 1
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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.
Detailed Description
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 juncti...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- Acute hydrocephaly
- Other type of Chiari disease (induced…)
- Medical history of neurosurgery
- Contraindication for MRI
- Cophosis
- 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
- Cophosis
- 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
Exclusion
Key Trial Info
Start Date :
December 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2020
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03295864
Start Date
December 20 2017
End Date
February 17 2020
Last Update
September 9 2021
Active Locations (1)
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1
CHU de Bordeaux
Bordeaux, France, 33076