Central Manchester University Hospitals NHS Foundation Trust
Manchester, Manchester (Manchester Borough), M13 9WL, United Kingdom
NCT Number: NCT02246231
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Manchester, Manchester (Manchester Borough), M13 9WL, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Children under the age of 18 years Claustrophobia Bilateral implants
Contraindications and relative contraindications for MRI (as per the Radiology Department MRI protocol) including:
Pacemaker Certain metallic heart valves Ferromagnetic implanted materials and foreign bodies
Time frame: 1 year
Time frame: 1 year
Manchester University NHS Foundation Trust
Other Gov
The Effect of Changes in Head Position on Magnetic Resonance Image Distortion in Patients With Auditory Implants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02129647
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Cranial Nerve Diseases
New York, United States
View Trial DetailsNCT02934256
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Cranial Nerve Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT01767792
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Cranial Nerve Diseases
Los Angeles, California, United States
View Trial DetailsNCT01125046
Acoustic Schwannoma, Adult Anaplastic Meningioma
Chicago, Illinois, United States
View Trial Details