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

Primary Purpose

Arnold-Chiari Malformation, Type 1

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multifrequency tympanometry at Inclusion
Multifrequency tympanometry 6 month after surgery
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arnold-Chiari Malformation, Type 1 focused on measuring Arnold-Chiari Malformation, Type 1, Multifrequency tympanometry, Inner ear pressure

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with Chiari type 1 malformation

Healthy volunteers

Arm Description

Tympanometry measurement at inclusion and 6 months after surgery

Tympanometry measurement at inclusion. Every healthy volunteer will be match with a patient for his age and his BMI (body mass index).

Outcomes

Primary Outcome Measures

Width of conductance tympanograms at 2 kHz measurement

Secondary Outcome Measures

Multifrequency tympanometry
Resonance frequency
Audiometric parameters
Otological symptoms
Pain measurement with Headache Impact Test
Cerebro spinal fluid pressure of the cranio cervical junction

Full Information

First Posted
September 14, 2017
Last Updated
September 8, 2021
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03295864
Brief Title
Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment
Acronym
MCoto
Official Title
Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
February 17, 2020 (Actual)
Study Completion Date
February 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arnold-Chiari Malformation, Type 1
Keywords
Arnold-Chiari Malformation, Type 1, Multifrequency tympanometry, Inner ear pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with Chiari type 1 malformation
Arm Type
Experimental
Arm Description
Tympanometry measurement at inclusion and 6 months after surgery
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
Tympanometry measurement at inclusion. Every healthy volunteer will be match with a patient for his age and his BMI (body mass index).
Intervention Type
Diagnostic Test
Intervention Name(s)
Multifrequency tympanometry at Inclusion
Intervention Description
Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed for both group at inclusion
Intervention Type
Diagnostic Test
Intervention Name(s)
Multifrequency tympanometry 6 month after surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
Width of conductance tympanograms at 2 kHz measurement
Time Frame
Inclusion
Secondary Outcome Measure Information:
Title
Multifrequency tympanometry
Time Frame
Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Title
Resonance frequency
Time Frame
Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Title
Audiometric parameters
Time Frame
Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Title
Otological symptoms
Time Frame
Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, MD
Organizational Affiliation
USMR - CHU de Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

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

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