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

September 8, 2021 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with Chiari type 1 malformation
Tympanometry measurement at inclusion and 6 months after surgery
Diagnostic test: Multifrequency tympanometry at Inclusion
Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed for both group at inclusion
Diagnostic test: Multifrequency tympanometry 6 month after surgery
Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed 6 months after surgery for Chiari type I malformation patient
Experimental: Healthy volunteers
Tympanometry measurement at inclusion. Every healthy volunteer will be match with a patient for his age and his BMI (body mass index).
Diagnostic test: Multifrequency tympanometry at Inclusion
Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed for both group at inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Width of conductance tympanograms at 2 kHz measurement
Time Frame: Inclusion
Inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Multifrequency tympanometry
Time Frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Resonance frequency
Time Frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Audiometric parameters
Time Frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Otological symptoms
Time Frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
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
Time Frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
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
Time Frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Study Chair: Antoine BENARD, MD, USMR - CHU de Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2017

Primary Completion (Actual)

February 17, 2020

Study Completion (Actual)

February 17, 2020

Study Registration Dates

First Submitted

September 14, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

September 9, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2016/36

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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