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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03295864
Recruitment Status : Completed
First Posted : September 28, 2017
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Arnold-Chiari Malformation, Type 1 Diagnostic Test: Multifrequency tympanometry at Inclusion Diagnostic Test: Multifrequency tympanometry 6 month after surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment
Actual Study Start Date : December 20, 2017
Actual Primary Completion Date : February 17, 2020
Actual Study Completion Date : February 17, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with Chiari type 1 malformation
Tympanometry measurement at inclusion and 6 months after surgery
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

Diagnostic Test: 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

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




Primary Outcome Measures :
  1. Width of conductance tympanograms at 2 kHz measurement [ Time Frame: Inclusion ]

Secondary Outcome Measures :
  1. Multifrequency tympanometry [ Time Frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation ]
  2. Resonance frequency [ Time Frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation ]
  3. Audiometric parameters [ Time Frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation ]
  4. Otological symptoms [ Time Frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation ]
  5. 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 ]
  6. 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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295864


Locations
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France
CHU de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Antoine BENARD, MD USMR - CHU de Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03295864    
Other Study ID Numbers: CHUBX 2016/36
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Arnold-Chiari Malformation, Type 1
Multifrequency tympanometry
Inner ear pressure
Additional relevant MeSH terms:
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Arnold-Chiari Malformation
Congenital Abnormalities
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases