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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

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

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

NCT ID

NCT03295864

First Posted

September 14, 2017

Last Updated

September 8, 2021

Sponsor

University Hospital, Bordeaux

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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