Status:
COMPLETED
Analysis and Reducing Modalities for Artefacts Generated by Bone Conduction Implants and Cochlear Implants Subjected to an MRI Magnetic Field
Lead Sponsor:
Ramsay Générale de Santé
Collaborating Sponsors:
Dr Arnaud Devèze
Conditions:
Hearing Implants
Implant Hearing Artefact
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Investigator team hypothesize that artifacts generated by the presence of an acoustic implant subjected to the magnetic field of the MRI are variable depending on the type of sequence and can be reduc...
Detailed Description
Little scientific data is available on the artifacts generated by hearing implants. Indeed, hearing rehabilitation for deaf people was given priority over the potential constraints of imaging. Investi...
Eligibility Criteria
Inclusion
- 18 years old or more
- free of otological, neurological or psychiatric pathology
- absence of contraindication to MRI \*
- free and informed consent signed
Exclusion
- minor subject, major guardianship or trusteeship and major protected under the law (pregnant women, nursing, parturiante, persons deprived of their liberty)
- suject carrier of an implantable device or para magnetic
- contraindication to MRI \*
- revious otological pathology, tinnitus, deafness
- revious cerebral pathology
- unable to understand the objectives, issues and risks of the study and to give free and informed consent.
- Contraindications to MRI are:
- Claustrophobia Anxiety attack Morphotype does not allow access to MRI
- Wearing a metal implant, for example:
- a pacemaker
- ferromagnetic surgical clips
- foreign bodies
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04116788
Start Date
November 15 2017
End Date
September 30 2018
Last Update
October 8 2019
Active Locations (1)
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1
Clairval Private Hospital
Marseille, PACA, France, 13009