Ignite Creation Date:
2024-05-06 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02984202
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2016-11-21
Brief Title:
Auditory Midbrain Implant Study
Sponsor:
Hannover Medical School
Organization:
Hannover Medical School
Study Overview
Official Title:
Phase I Safety Study for a New Two-Shank Auditory Midbrain Implant AMI
Status:
COMPLETED
Status Verified Date:
2020-07
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:
The objectives of the clinical study are to implant five deaf patients those with Neurofibromatosis Type II NF2 with a new two-shank auditory midbrain implant array AMI developed by Cochlear Limited into the central nucleus of the inferior colliculus in order to assess the safety reliability consistency of placement and performance of the AMI device The clinical trial is being performed at Hannover Medical School in Germany in collaboration with University of Minnesota USA and Cochlear Limited Australia The clinical trial is being managed by Hannover Clinical Trial Center in Germany
Detailed Description:
Cochlear implants are used in the cochlea part of the inner ear where they send electrical signals for activation of the auditory nerve to restore hearing to deaf patients For patients without a functioning auditory nerve there is an auditory brainstem implant ABI which is placed on the surface of the brainstem in a more central location to restore hearing Unfortunately the hearing performance of the ABI is typically lower than the performance of the cochlear implant There are several reasons for the lower success of the ABI Due to the tumor andor tumor removal process for the NF2 condition there is potential damage caused at the brainstem level that has been linked to the poorer performance The anatomical changes caused by the tumor also make it difficult to properly visualize and place the ABI surface array into the correct location In addition if there is a large tumor that needs to or has been removed then there can be a large cavity in the brainstem space with the possibility that the ABI surface array can move from its initial location over time
Therefore for the past 16 years a new implant has been developed in an international collaboration that presents electrical stimuli into a midbrain region the inferior colliculus This new implant is called the auditory midbrain implant AMI The current version consists of two shanks with with 11 electrode contacts linearly spaced along each shank The two shanks are inserted into the inferior colliculus to align the electrodes along different pitch layers to be able to stimulate them individually with varying temporal pulse patterns
In the period from 2006 to 2010 a former version of the current AMI was implanted and evaluated in five NF2 deaf patients for hearing restoration This first AMI implant consisted of only one shank in contrast with the current two-shank array Encouragingly the clinical trial at that time showed that the AMI was safe for all five patients All patients achieved improvements in their hearing capacity especially in the form of environmental sound awareness and lip-reading enhancement One patient additionally attained good speech perception that is within the upper range of ABI NF2 patients However this speech perception is not yet at the level that can be attained in cochlear implant patients
Based on these experiences and additional studies in animals we have developed the second version of the AMI that consists of two shanks that will be implanted into the inferior colliculus and is expected to provide significant improvements in hearing performance compared to the previous AMI by stimulating more effectively across the three-dimensional inferior colliculus
The purpose of this clinical trial is to evaluate the safety reliability and performance of the new two-shank AMI in deaf NF2 patients The ability to consistency place the AMI array into the inferior colliculus will also be evaluated
Therefore for the past 16 years a new implant has been developed in an international collaboration that presents electrical stimuli into a midbrain region the inferior colliculus This new implant is called the auditory midbrain implant AMI The current version consists of two shanks with with 11 electrode contacts linearly spaced along each shank The two shanks are inserted into the inferior colliculus to align the electrodes along different pitch layers to be able to stimulate them individually with varying temporal pulse patterns
In the period from 2006 to 2010 a former version of the current AMI was implanted and evaluated in five NF2 deaf patients for hearing restoration This first AMI implant consisted of only one shank in contrast with the current two-shank array Encouragingly the clinical trial at that time showed that the AMI was safe for all five patients All patients achieved improvements in their hearing capacity especially in the form of environmental sound awareness and lip-reading enhancement One patient additionally attained good speech perception that is within the upper range of ABI NF2 patients However this speech perception is not yet at the level that can be attained in cochlear implant patients
Based on these experiences and additional studies in animals we have developed the second version of the AMI that consists of two shanks that will be implanted into the inferior colliculus and is expected to provide significant improvements in hearing performance compared to the previous AMI by stimulating more effectively across the three-dimensional inferior colliculus
The purpose of this clinical trial is to evaluate the safety reliability and performance of the new two-shank AMI in deaf NF2 patients The ability to consistency place the AMI array into the inferior colliculus will also be evaluated
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