Auditory Midbrain Implant Study

NCT02984202 | Completed DMC

• 1 other identifier: NIH U01 DC013030
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Deafness; Perception

Outcome Measures

Primary Outcomes (2)

• Collection of serious adverse events of AMI

  Collection of investigational device related serious adverse events during the evaluation period.

  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.

  24 months

Secondary Outcomes (1)

• Speech perception performance of AMI

  24 months

Study Arms (1)

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.

Device: auditory midbrain implant (AMI)

Interventions

auditory midbrain implant (AMI) DEVICE

Safety/Efficacy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead
• University of Minnesota: collaborator
• Cochlear: collaborator

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: December 6, 2016
• Study Start: October 17, 2016
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: August 3, 2020

Record last verified: 2020-07

Locations

DE (1)