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Auditory Brainstem Implant (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects

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ClinicalTrials.gov Identifier: NCT01736267
Recruitment Status : Recruiting
First Posted : November 29, 2012
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Daniel Lee, Massachusetts Eye and Ear Infirmary

Study Description
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Brief Summary:
The purpose of this research study is to determine whether Auditory Brainstem Implant (ABI) can improve hearing in persons who are deaf in both ears and are not candidates for cochlear implants.

Condition or disease Intervention/treatment Phase
Bilateral Hearing Loss for Causes Other Than Tumors Device: Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI) Not Applicable

Detailed Description:
The goal of this MEEI Auditory Brainstem Implant (ABI) research study is to find new ways to improve hearing in patients who are deaf and cannot receive a cochlear implant. The ABI is a surgically placed bionic implant that converts sounds into electrical signals that are directly transmitted to the cochlear nucleus, the first auditory center of the brain. For many years, ABIs have improved the hearing of patients who are deaf due to brain tumors associated with a genetic syndrome called Neurofibromatosis Type 2 (NF2). However, a number of recent studies suggest that deaf patients who do not have NF2 and are not eligible for a cochlear implant may also benefit from placement of an ABI. These preliminary studies suggest that these non-NF2 or "nontumor" patients may actually have better outcomes after ABI surgery than patients suffering from NF2. Patients who do not have NF2 and are deaf due to damage to the hearing nerves or inner ears from infection, disease or injury are not cochlear implant candidates and there are no other options to improve hearing in these cases except for the ABI. Thus, the purpose of our study is to carefully analyze whether ABI surgery improves the hearing and quality of life of non-NF2 patients based on subjective and objective measures of their hearing before and after ABI surgery. In particular, we plan to study ABI outcomes in non-NF2 patients, characterize the parameters used on their devices, and determine the safety profile of ABIs in these patients.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Nucleus 24 and ABI541 Auditory Brainstem Implants (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects
Study Start Date : November 2012
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Non-NF2 ABI surgery
All subjects will be part of a single arm involving placement of the Nucleus ABI541 Auditory Brainstem Implant (ABI) device. The Nucleus 24 was discontinued and is no longer available.
 Device: Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)
Nucleus ABI541 Auditory Brainstem Implant (ABI) surgery followed by device activation, testing, and clinical assessment for five years following surgery.
Other Name: ABI, Nucleus 24, Cochlear Americas, ABI541, Nucleus Profile


Outcome Measures
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Primary Outcome Measures :
  1. Perioperative and postoperative complications [ Time Frame: 5 years from date of surgery ]
    We will track any major and minor complications intraoperatively and postoperatively in all study participants.

  2. Audiologic performance [ Time Frame: 5 years from date of surgery ]
    We will complete physiological, psychophysical, and speech based tests to determine audiologic performance following ABI surgery.

  3. ABI electrophysiologic parameters [ Time Frame: 5 years from date of surgery ]
    We will examine parameters for electrode activation postoperatively in all study participants.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • English as the primary language
  • Medically and psychologically suitable
  • Willing to receive/have received meningitis / pneumococcal vaccinations
  • Able to comply with study requirements, including travel to the investigational site

  • Cochlear or retrocochlear anomaly/pathology that interferes with transmission of auditory information from the cochleae to the brainstem, resulting in severe to profound bilateral deafness (thresholds of 90 dB or worse in both ears on pure tone audiometry ranging from 250 to 2,000 Hz and speech recognition scores ≤ 30% in both ears). All subjects will undergo bone conduction audiometry and tympanometry to confirm sensorineural hearing loss and rule out potential middle ear disorders.

    • Conditions that cannot be otherwise treated, with conventional hearing aids or cochlear implants. If CI were previously used, subjects will have had a failed response, defined as ≤ 30% speech recognition and patient perception of inadequate benefit to continue using the device.

    • Expected subjects include those with these diagnoses:

      • Bilaterally severe/completely ossified cochleae
      • Bilateral cochlear malformations leading to poor CI outcomes
      • Bilateral temporal bone fractures, where the VIIIth cranial nerves have been disrupted
      • Bilateral cochlear nerve agenesis
      • Not a CI candidate based on above listed pathology, intolerable adverse effects with CI (e.g. stimulation of the facial nerve), or Evoked Auditory Potential testing predictive of a poor response

Exclusion Criteria:

  • Anomalies/pathology involving the brainstem or cortex
  • Retrocochlear pathology due to NF2 or other types of cranial nerve or brainstem neoplasm
  • Co-existing medical conditions that require irradiation of the brainstem or auditory cortex
  • Medical or psychological conditions that serve as contraindication to surgery
  • Additional handicaps that would prevent or limit participation in evaluations
  • Unrealistic patient or family expectations regarding the benefits, risks, and limitations inherent to the procedure and the prosthetic device
  • Pregnant women
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736267


Contacts
Contact: Daniel J Lee, MD, FACS 617-573-3130 daniel_lee@meei.harvard.edu
Contact: Barbara S Herrmann, PhD, CCC-A 617-573-3266 barbara_herrmann@meei.harvard.edu

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Daniel Lee, MD, FACS    617-573-3130    daniel_lee@meei.harvard.edu   
Contact: Sidharth Puram, MD    617-571-4049    Sidharth_Puram@MEEI.HARVARD.EDU   
Principal Investigator: Daniel J Lee, MD, FACS         
Sub-Investigator: Barbara Herrmann, PhD, CCC-A         
Sub-Investigator: Sidharth V Puram, MD         
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Daniel J Lee, MD, FACS MEEI, HMS, MGH
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dr. Daniel Lee, Director of Auditory Brainstem Implant Progra, Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01736267     History of Changes
Other Study ID Numbers: MEEI HSC 12-061
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Keywords provided by Dr. Daniel Lee, Massachusetts Eye and Ear Infirmary:
Auditory Brainstem Implant
ABI
Nucleus 24
Deafness
 Hearing loss
Non-tumor
Non-NF2
ABI541

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Bilateral
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms