Analysis and Reducing Modalities for Artefacts Generated by Bone Conduction Implants and Cochlear Implants Subjected to an MRI Magnetic Field (Artefact)
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|ClinicalTrials.gov Identifier: NCT04116788|
Recruitment Status : Completed
First Posted : October 7, 2019
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hearing Implants Implant Hearing Artefact||Device: Artefact IRM assessment||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Analysis and Reducing Modalities for Artefacts Generated by Bone Conduction Implants and Cochlear Implants Subjected to an MRI Magnetic Field - Artefact|
|Actual Study Start Date :||November 15, 2017|
|Actual Primary Completion Date :||September 29, 2018|
|Actual Study Completion Date :||September 30, 2018|
- Device: Artefact IRM assessment
- Artefact surface ratio [ Time Frame: 1 day ]
The primary endpoint will be the percentage of artefact area (SA) induced by the magnetic implant relative to the overall sectional area of the artifactless skull section (SC).
The measured artefact surface will therefore be related to the reference surface and the artefact percentage will be calculated by the following formula:
Ratio (R) = Area artifact (SA) / Area cut (SC) * 100
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116788
|Clairval Private Hospital|
|Marseille, Paca, France, 13009|