Analysis and Reducing Modalities for Artefacts Generated by Bone Conduction Implants and Cochlear Implants Subjected to an MRI Magnetic Field

NCT ID: NCT04116788

Last Updated: 2019-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2018-09-30

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 reduced by structural modifications of the implant and by variations in its appearance positioning with respect to the magnetic field MRI.

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. Investigator team find less than 10 articles with a search of following keywords on the pubmed database: Artifacts AND MRI AND cochlear implants. Only one of these articles deals with demagnetization. There is only one article dealing with artifacts with the Bonebridge implant. There are no studies with the Attract implant and a recent one with the new Synchrony mobile magnet implant, but by removing the magnet which implies a minimum response time and therefore not compatible with emergency care.

In total, the literature is quite poor mainly considering the priority of auditory rehabilitation on the realization of subsequent imaging.

However, the current "democratization" of hearing implants and their increasing use in children and adults requires reflection on not only the safety of examinations of healthy volunteers, but also of the implant itself. also on the relevance of the interpretation of imaging especially cerebral.

The pilot study done, suggested that the placement of the implant (in this case the Bonebridge) has an influence on the size of the artifact and the possibilities of interpretation.

It seems appropriate to continue this protocol of analysis, both on the implants in bone conduction, and also on the cochlear implants to demonstrate the impact of the implant on the MRI images and also the impact of the magnetic field on the implant itself, and possibly publish recommendations for clinical practice.

Conditions

Hearing Implants; Implant Hearing Artefact

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

Artefact IRM assessment

IRM

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 years old or more
• free of otological, neurological or psychiatric pathology
• absence of contraindication to MRI *
• free and informed consent signed

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr Arnaud Devèze

UNKNOWN

Sponsor Role: collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clairval Private Hospital

Marseille, PACA, France

Countries

France

Other Identifiers

2016-A01036-45

Identifier Type: -

Identifier Source: org_study_id