Arnold-Chiari Malformation, Type 1MCotoNCT03295864
Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment
A study testing Multifrequency tympanometry at Inclusion and Multifrequency tympanometry 6 month after surgery in people with Arnold-Chiari Malformation, Type 1, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Arnold-Chiari Malformation, Type 1
- What is being tested?
- Multifrequency tympanometry at Inclusion and Multifrequency tympanometry 6 month after surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2017to 17 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Between 18 and 60 years old.
- Free of otologic pathology
- Benefit of the national health care system
- Agreement of the volunteers
Who cannot join
- Acute hydrocephaly
- Other type of Chiari disease (induced…)
- Medical history of neurosurgery
- Contraindication for MRI
- Cophosis
- Chronic otitis
Show all 21Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Arnold-Chiari Malformation, Type 1
- Being tested
- Multifrequency tympanometry at Inclusion, Multifrequency tympanometry 6 month after surgery
- Keywords
- Arnold-Chiari Malformation, Type 1, Multifrequency tympanometry, Inner ear pressure
- Medical subject headings
- Arnold-Chiari Malformation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifrequency tympanometry at InclusionDiagnostic test
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 surgeryDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Patients with Chiari type 1 malformation | Experimental | Tympanometry measurement at inclusion and 6 months after surgery Receives: Diagnostic Test: Multifrequency tympanometry at Inclusion; Diagnostic Test: Multifrequency tympanometry 6 month after surgery |
| Healthy volunteers | Experimental | Tympanometry measurement at inclusion. Every healthy volunteer will be match with a patient for his age and his BMI (body mass index). Receives: Diagnostic Test: Multifrequency tympanometry at Inclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Width of conductance tympanograms at 2 kHz measurement
Measured: Inclusion
Secondary outcomes (6)
Multifrequency tympanometry
Measured: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Resonance frequency
Measured: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Audiometric parameters
Measured: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Otological symptoms
Measured: 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
Measured: 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
Measured: Inclusion and 6 months after surgery for patients with an indication of surgical management for a Chiari type I malformation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start20 Dec 2017
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arnold-Chiari Malformation, Type 1Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine BENARD, MD, Study chair, USMR - CHU de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295864
- Sponsor's protocol ID
- CHUBX 2016/36
- Acronym
- MCoto
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2017
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment
- ClinicalTrials.gov ID
- NCT03295864
- Acronym / sponsor ID
- MCoto / CHUBX 2016/36
- Conditions
- Arnold-Chiari Malformation, Type 1
- Keywords
- Arnold-Chiari Malformation, Type 1, Multifrequency tympanometry, Inner ear pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Chiari type 1 malformation | Experimental | Diagnostic Test: Multifrequency tympanometry at Inclusion, Diagnostic Test: Multifrequency tympanometry 6 month after surgeryTympanometry measurement at inclusion and 6 months after surgery |
| Healthy volunteers | Experimental | Diagnostic Test: Multifrequency tympanometry at InclusionTympanometry measurement at inclusion. Every healthy volunteer will be match with a patient for his age and his BMI (body mass index). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
- Between 18 and 60 years old.
Key exclusion criteria (21 listed)
- Acute hydrocephaly
- Other type of Chiari disease (induced…)
- Medical history of neurosurgery
- Contraindication for MRI
- Cophosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifrequency tympanometry at InclusionMultifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed for both group at inclusion | Diagnostic test | Healthy volunteers, Patients with Chiari type 1 malformation |
| Multifrequency tympanometry 6 month after surgeryMultifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed 6 months after surgery for Chiari type I malformation patient | Diagnostic test | Patients with Chiari type 1 malformation |
Primary outcome
Width of conductance tympanograms at 2 kHz measurement
Time frame: Inclusion
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine BENARD, MD study chair
USMR - CHU de Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifrequency tympanometry at Inclusion and Multifrequency tympanometry 6 month after surgery in people with Arnold-Chiari Malformation, Type 1, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Width of conductance tympanograms at 2 kHz measurement (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.