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History of Changes for Study: NCT03295864
Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment (MCoto)
Latest version (submitted September 8, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 25, 2017 None (earliest Version on record)
2 December 20, 2017 Recruitment Status, Study Status and Contacts/Locations
3 January 2, 2019 Study Status
4 February 12, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
5 September 8, 2021 Recruitment Status, Study Status and Study Design
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Study NCT03295864
Submitted Date:  September 25, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: CHUBX 2016/36
Brief Title: Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment (MCoto)
Official Title: Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2017
Overall Status: Not yet recruiting
Study Start: November 2017
Primary Completion: November 2019 [Anticipated]
Study Completion: November 2020 [Anticipated]
First Submitted: September 14, 2017
First Submitted that
Met QC Criteria:
September 25, 2017
First Posted: September 28, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
September 25, 2017
Last Update Posted: September 28, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University Hospital, Bordeaux
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Arnold-Chiari Malformation, Type 1
Keywords: Arnold-Chiari Malformation, Type 1
Multifrequency tympanometry
Inner ear pressure
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 50 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Vincent JECKO, MD
Telephone: (0)5 56 79 55 43 Ext. +33
Email: vincent.jecko@chu-bordeaux.fr
Central Contact Backup: Olivier BRANCHARD
Telephone: (0)5 57 82 06 97 Ext. +33
Email: olivier.branchard@chu-bordeaux.fr
Study Officials: Antoine BENARD, MD
Study Chair
USMR - CHU de Bordeaux
Locations: France
CHU de Bordeaux
Bordeaux, France, 33076
Contact:Contact: Vincent JECKO, MD (0)5 56 79 55 43 Ext. +33 vincent.jecko@chu-bordeaux.fr
Contact:Contact: Olivier BRANCHARD (0)5 56 82 06 97 Ext. +33 olivier.branchard@chu-bordeaux.fr
Contact:Principal Investigator: Vincent JECKO, MD
Contact:Sub-Investigator: Valérie FRANCO VIDAL, MD-PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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