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Clinical Trials/NCT03295864
NCT03295864
Completed
N/A

Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment

University Hospital, Bordeaux1 site in 1 country49 target enrollmentDecember 20, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Arnold-Chiari Malformation, Type 1
Sponsor
University Hospital, Bordeaux
Enrollment
49
Locations
1
Primary Endpoint
Width of conductance tympanograms at 2 kHz measurement
Status
Completed
Last Updated
4 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
December 20, 2017
End Date
February 17, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Width of conductance tympanograms at 2 kHz measurement

Time Frame: Inclusion

Secondary Outcomes

  • 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)

Study Sites (1)

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