- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02984202
Auditory Midbrain Implant Study
Phase I Safety Study for a New Two-Shank Auditory Midbrain Implant (AMI)
Study Overview
Status
Conditions
Intervention / Treatment
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 and/or 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lower Saxony
-
Hannover, Lower Saxony, Germany, 30625
- Hannover Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥18 and ≤75 years
- Diagnosis of NF2 (i.e., Neurofibromatosis Type 2)
- Bilateral deafness without a functional auditory nerve or insufficient residual hearing while being ineligible for cochlear implant
- Eligible for brainstem or midbrain surgery for a standard clinical procedure, including to remove a tumor, replace or reposition an existing ABI, or implant a new ABI
- No or minimal benefit from a previously implanted auditory brainstem implant (ABI) (i.e. patient has requested an alternative hearing option due to insufficient benefit on a daily basis); or poor performance expected with an ABI due to a high risk of array movement associated with removal of a large tumor or anatomical abnormalities/damage (e.g., associated with altered development, tumor compression, radiation therapy, surgical intervention, or other treatments)
- No further lesions of the auditory pathway from the inferior colliculus (IC) to the auditory cortex
- Post-linguistic onset of contralateral severe-to-profound neural hearing loss
- Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gynecologists
- Written informed consent
Exclusion Criteria:
- Medical, neurological, or psychological conditions that would contra-indicate undergoing surgery, e.g. acute cardiac infarction, history of stroke, dementia
- Additional handicaps that would prevent participation in evaluations
- Pregnant and breast feeding woman, prisoners, or anyone in custody
- Known allergies to one of the components of the implant
- Other active devices with potential interference with brain implants, such as transcranial magnetic stimulators
- Additionally, in the event of other serious diseases (e.g. progressive carcinoma or chronic renal failure) the investigators will decide on a case-by-case basis whether to enroll the patient in the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Safety/Efficacy
Patients will be implanted with the AMI and evaluated for safety and efficacy over a 2-year period.
The placement of the AMI array into the inferior colliculus will also be evaluated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Collection of serious adverse events of AMI
Time Frame: 24 months
|
Collection of investigational device related serious adverse events during the evaluation period.
|
24 months
|
Position of AMI array in midbrain
Time Frame: 24 months
|
Evaluation of the final position of the two shanks of the AMI array in the inferior colliculus which includes angles and insertion locations of each shank relative to specific anatomical landmarks.
The frequency/pitch ordering of the sites along each shank will also be measured which provides how many electrode sites are correctly positioned into the inferior colliculus and thus the depth location of each shank relative to the surface of the midbrain.
All of these measurements provide the final position of the AMI array in the midbrain.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech perception performance of AMI
Time Frame: 24 months
|
Relative difference of the speech perception score between current ABI recipients with NF2 (collected data from the same clinical site) and AMI recipients with NF2 at the two-year post-operative evaluation visit.
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIH U01 DC013030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Deafness; Perception
-
Hôpital RothschildCompletedDeafness; Perception, Bilateral
-
University Hospital, GrenobleCentre National de la Recherche Scientifique, FranceCompletedDeafness; Perception, BilateralFrance
-
Cliniques universitaires Saint-Luc- Université...Unknown
-
Aaron NewmanTerminatedHearing Loss | Deafness and Auditory PerceptionCanada
-
University of ZurichTerminatedVerticality Perception | Self-motion PerceptionSwitzerland
-
Pacific Northwest University of Health SciencesCadwell Industries, Inc.TerminatedDeafness | Sound Perception | Quality of SoundUnited States
-
Brigham and Women's HospitalCompletedDecision Making | Form Perception | Color PerceptionUnited States
-
Ryerson UniversityMitacs; Sonova AGTerminatedAging | Hearing Loss | Music Therapy | Auditory PerceptionCanada
-
Portland VA Medical CenterCompletedHearing Impairment | Memory | Auditory PerceptionUnited States
-
University of MontanaCompleted
Clinical Trials on auditory midbrain implant (AMI)
-
University Medical Center GroningenMED-EL Elektromedizinische Geräte GesmbHRecruiting
-
FDA Office of Orphan Products DevelopmentCompletedNeurofibromatosis 2United States
-
NYU Langone HealthRecruitingHearing Loss, Bilateral (Causes Other Than Tumors)United States
-
FDA Office of Orphan Products DevelopmentCochlearCompleted
-
Massachusetts Eye and Ear InfirmaryNo longer availableNeurofibromatosis Type 2 | Severe Profound Sensorineural Hearing LossUnited States
-
Laurie EisenbergChildren's Hospital Los Angeles; Huntington Medical Research Institutes; Keck...UnknownProfound Bilateral Deafness Due to | Bilateral Cochlear Aplasia | Bilateral Cochlear Nerve Deficiency | Bilateral Cochlear Ossification Secondary to MeningitisUnited States
-
House Research InstituteChildren's Hospital Los Angeles; House Clinic, Inc.WithdrawnBilateral Cochlear Aplasia | Bilateral Cochlear Nerve Deficiency | Bilateral Cochlear Ossification Secondary to MeningitisUnited States
-
Hospital Universitario La PazMED-EL Elektromedizinische Geräte GesmbHRecruitingQuality of Life | Hearing Loss, Mixed | Bone Conduction DeafnessSpain
-
University of Maryland, College ParkVanderbilt University; National Institute on Deafness and Other Communication...Enrolling by invitationAging | Hearing Loss | Hearing Loss, Sensorineural | Cochlear Hearing LossUnited States
-
Nils GuinandMaastricht University Medical Center; Massachusetts Eye and Ear Infirmary; University...RecruitingBilateral Vestibulopathy | Vestibular Disorder | Bilateral Vestibular LossSwitzerland