Ignite Creation Date:
2024-05-06 @ 3:16 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02246231
Status:
COMPLETED
Last Update Posted:
2020-03-17
First Post:
2014-09-18
Brief Title:
Effect of Implant Position on Magnetic Resonance Image Distortion
Sponsor:
Manchester University NHS Foundation Trust
Organization:
Manchester University NHS Foundation Trust
Study Overview
Official Title:
The Effect of Changes in Head Position on Magnetic Resonance Image Distortion in Patients With Auditory Implants
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with Neurofibromatosis type 2 NF2 almost always develop acoustic neuromas in both ears As a result of the tumours themselves or the treatment of the tumours many patients become profoundly deaf in both ears It is possible to restore a degree of hearing by placing a hearing implant in the brainstem adjacent to the hearing pathways within the brain This is termed an auditory brainstem implant ABI
The aim of this study is to find the optimum head position in relation to the MRI magnet field which would produce least area of image distortion in patients with ABIs This will be of benefit in optimising the MR imaging in future patients with implants
The aim of this study is to find the optimum head position in relation to the MRI magnet field which would produce least area of image distortion in patients with ABIs This will be of benefit in optimising the MR imaging in future patients with implants
Detailed Description:
Auditory brainstem implants ABI are placed against the auditory centres in the brainstem if it is not possible to implant the cochlea or if the cochlear nerve which conveys neural signals from the cochlea to the brainstem is damaged or absent The latter device is usually used in patients with Neurofibromatosis type 2 NF2 who develop bilateral benign inner ear tumours called vestibular schwannomas as well as other neurological tumours1 These patients often become bilaterally profoundly deaf either as a result of the disease or because of surgery to remove the tumours and require an ABI
Patients with NF2 require monitoring of their tumours In the absence of an auditory implant it is possible to use magnetic resonance imaging This is the gold standard imaging technique as it gives excellent views of the soft tissues of head However there has been concern regarding the use of MRI in patients with auditory implants until recently because of potential problems such as demagnetisation of the magnet within the implant implant magnet displacement and risk to the integrity of the implant electronics In addition the magnet field of the implant magnet results in imaging artefact manifesting as a signal void around the implant site that limits the information that can be obtained
Patients with NF2 require monitoring of their tumours In the absence of an auditory implant it is possible to use magnetic resonance imaging This is the gold standard imaging technique as it gives excellent views of the soft tissues of head However there has been concern regarding the use of MRI in patients with auditory implants until recently because of potential problems such as demagnetisation of the magnet within the implant implant magnet displacement and risk to the integrity of the implant electronics In addition the magnet field of the implant magnet results in imaging artefact manifesting as a signal void around the implant site that limits the information that can be obtained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None