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

Arnold-Chiari Malformation, Type 1 Clinical Trial

— MCoto  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295864
• Other study ID #: CHUBX 2016/36
• Status: Completed
• Phase: N/A
• Start date: December 20, 2017
• Est. completion date: February 17, 2020

Study information

• Verified date: September 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 17, 2020
• Est. primary completion date: February 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Arnold-Chiari Malformation
• Arnold-Chiari Malformation, Type 1
• Congenital Abnormalities

Intervention

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
• 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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Width of conductance tympanograms at 2 kHz measurement		Inclusion
Secondary	Multifrequency tympanometry		Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Secondary	Resonance frequency		Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Secondary	Audiometric parameters		Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Secondary	Otological symptoms		Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Secondary	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
Secondary	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