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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03295864
Acronym
MCoto
Enrollment
49
Registered
2017-09-28
Start date
2017-12-20
Completion date
2020-02-17
Last updated
2021-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arnold-Chiari Malformation, Type 1

Keywords

Arnold-Chiari Malformation, Type 1, Multifrequency tympanometry, Inner ear pressure

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.

Interventions

DIAGNOSTIC_TESTMultifrequency tympanometry at Inclusion

Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed for both group at inclusion

DIAGNOSTIC_TESTMultifrequency 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

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Width of conductance tympanograms at 2 kHz measurementInclusion

Secondary

MeasureTime frame
Resonance frequencyInclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Audiometric parametersInclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Multifrequency tympanometryInclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Pain measurement with Headache Impact TestInclusion 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 junctionInclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Otological symptomsInclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026