Effect of Implant Position on Magnetic Resonance Image Distortion
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02246231|
Recruitment Status : Unknown
Verified September 2014 by Hayley Brooks, Manchester University NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : September 22, 2014
Last Update Posted : September 22, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Neurofibromatosis Type 2||Device: MR imaging||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Changes in Head Position on Magnetic Resonance Image Distortion in Patients With Auditory Implants|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||January 2015|
|Experimental: NF2 who has an auditory implant||
Device: MR imaging
- To study the effect of magnet orientation in auditory brainstem implants/ cochlear implants in determining the size of signal void seen on MRI scanning. [ Time Frame: 1 year ]
- To identify if there is an angle at which the signal void is minimised [ Time Frame: 1 year ]
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): NCT02246231
|Contact: Hayley Brooksfirstname.lastname@example.org|
|Central Manchester University Hospitals NHS Foundation Trust||Recruiting|
|Manchester, Manchester (Manchester borough), United Kingdom, M13 9WL|
|Contact: Hayley Brooks 01612764902 email@example.com|
|Principal Investigator: Simon Lloyd|
|Principal Investigator:||Simon Lloyd||Manchester University NHS Foundation Trust|