Deafness; PerceptionNCT02984202
Auditory Midbrain Implant Study
A study testing auditory midbrain implant (AMI) in people with Deafness; Perception, run by Hannover Medical School at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Deafness; Perception
- What is being tested?
- auditory midbrain implant (AMI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- 17 Oct 2016to 25 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Safety Study for a New Two-Shank Auditory Midbrain Implant (AMI)
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.
Read the 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.
- Conditions
- Deafness; Perception
- Being tested
- auditory midbrain implant (AMI)
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auditory midbrain implant (AMI)Device
| Study group | Role | What they receive |
|---|---|---|
| Safety/Efficacy | Experimental | 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. Receives: Device: auditory midbrain implant (AMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of serious adverse events of AMI
Collection of investigational device related serious adverse events during the evaluation period.
Measured: 24 months
Position of AMI array in midbrain
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.
Measured: 24 months
Secondary outcomes (1)
Speech perception performance of AMI
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start17 Oct 2016
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deafness; PerceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Cochlear
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984202
- Sponsor's protocol ID
- NIH U01 DC013030
- Status last verified
- Jul 2020
- First submitted
- 21 Nov 2016
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety Study for a New Two-Shank Auditory Midbrain Implant (AMI)
- ClinicalTrials.gov ID
- NCT02984202
- Acronym / sponsor ID
- NIH U01 DC013030
- Conditions
- Deafness; Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- University of Minnesota, Cochlear
- Study start
- 17 Oct 2016 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety/Efficacy | Experimental | Device: auditory midbrain implant (AMI)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auditory midbrain implant (AMI) | Device | Safety/Efficacy |
Primary outcome
Collection of serious adverse events of AMI
Time frame: 24 months
Collection of investigational device related serious adverse events during the evaluation period.
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.
1 secondary outcome
Speech perception performance of AMI
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auditory midbrain implant (AMI) in people with Deafness; Perception, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of serious adverse events of AMI (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.