We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE September 14, 2017
First Posted Date  ICMJE September 28, 2017
Last Update Posted Date September 9, 2021
Actual Study Start Date  ICMJE December 20, 2017
Actual Primary Completion Date February 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2017)
Width of conductance tympanograms at 2 kHz measurement [ Time Frame: Inclusion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2017)
  • Multifrequency tympanometry [ Time Frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation ]
  • Resonance frequency [ Time Frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation ]
  • Audiometric parameters [ Time Frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation ]
  • Otological symptoms [ Time Frame: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment
Official Title  ICMJE Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Arnold-Chiari Malformation, Type 1
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Patients with Chiari type 1 malformation
    Tympanometry measurement at inclusion and 6 months after surgery
    Interventions:
    • Diagnostic Test: Multifrequency tympanometry at Inclusion
    • Diagnostic Test: Multifrequency tympanometry 6 month after surgery
  • 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).
    Intervention: Diagnostic Test: Multifrequency tympanometry at Inclusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2021)
49
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2017)
50
Actual Study Completion Date  ICMJE February 17, 2020
Actual Primary Completion Date February 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03295864
Other Study ID Numbers  ICMJE CHUBX 2016/36
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Bordeaux
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Bordeaux
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Antoine BENARD, MD USMR - CHU de Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP