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

University Hospital of Bordeaux

Status: Completed

Conditions: Arnold-Chiari Malformation, Type 1

Treatments: Diagnostic Test: Multifrequency tympanometry at Inclusion; Diagnostic Test: Multifrequency tympanometry 6 month after surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03295864

CHUBX 2016/36

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Patients with Chiari type 1 malformation

Experimental group

Description:

Tympanometry measurement at inclusion and 6 months after surgery

Treatment:

Diagnostic Test: Multifrequency tympanometry at Inclusion

Diagnostic Test: Multifrequency tympanometry 6 month after surgery

Healthy volunteers

Experimental group

Description:

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

Treatment:

Diagnostic Test: Multifrequency tympanometry at Inclusion