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

Not Applicable

Completed

• Conditions: Arnold-Chiari Malformation, Type 1
• Interventions: Diagnostic Test: Multifrequency tympanometry at Inclusion; Diagnostic Test: Multifrequency tympanometry 6 month after surgery

• Registration Number: NCT03295864
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2017-09-14
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-28
• Study Start: 2017-12-20
• Primary Completion: 2020-02-17
• Study Completion: 2020-02-17
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with Chiari type 1 malformation	Multifrequency tympanometry at Inclusion	Tympanometry measurement at inclusion and 6 months after surgery
Healthy volunteers	Multifrequency tympanometry at Inclusion	Tympanometry measurement at inclusion. Every healthy volunteer will be match with a patient for his age and his BMI (body mass index).
Patients with Chiari type 1 malformation	Multifrequency tympanometry 6 month after surgery	Tympanometry measurement at inclusion and 6 months after surgery

Primary Outcome Measures

Name	Time	Method
Width of conductance tympanograms at 2 kHz measurement	Inclusion

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France