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

This study is currently recruiting participants.
Verified October 2013 by Massachusetts Eye and Ear Infirmary
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01736267
First received: November 26, 2012
Last updated: October 31, 2013
Last verified: October 2013

November 26, 2012
October 31, 2013
November 2012
November 2022   (final data collection date for primary outcome measure)
  • Perioperative and postoperative complications [ Time Frame: 5 years from date of surgery ] [ Designated as safety issue: Yes ]
    We will track any major and minor complications intraoperatively and postoperatively in all study participants.
  • Audiologic performance [ Time Frame: 5 years from date of surgery ] [ Designated as safety issue: No ]
    We will complete physiological, psychophysical, and speech based tests to determine audiologic performance following ABI surgery.
  • ABI electrophysiologic parameters [ Time Frame: 5 years from date of surgery ] [ Designated as safety issue: No ]
    We will examine parameters for electrode activation postoperatively in all study participants.
  • Peri-operative and post-operative complications [ Time Frame: 5 years from date of surgery ] [ Designated as safety issue: Yes ]
    We will track any major and minor complications intra-operatively and post-operatively in all study participants.
  • Audiologic performance [ Time Frame: 5 years from date of surgery ] [ Designated as safety issue: No ]
    We will complete physiological, psychophysical, and speech based tests to determine audiologic performance following ABI surgery.
  • ABI electophysiologic parameters [ Time Frame: 5 years from date of surgery ] [ Designated as safety issue: No ]
    We will examine parameters for electrode activation post-operatively in all study participants.
Complete list of historical versions of study NCT01736267 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Auditory Brainstem Implant (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects
Study of Nucleus 24 Auditory Brainstem Implant (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bilateral Hearing Loss for Causes Other Than Tumors
Device: Nucleus 24 Auditory Brainstem Implant (ABI)
Nucleus 24 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
Experimental: Non-NF2 ABI surgery
All subjects will be part of a single arm involving placement of the Nucleus 24 Auditory Brainstem Implant (ABI) device.
Intervention: Device: Nucleus 24 Auditory Brainstem Implant (ABI)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
November 2022
November 2022   (final data collection date for primary outcome measure)

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 resulting from 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
Both
18 Years and older
No
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
United States
 
NCT01736267
MEEI HSC 12-061
No
Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
Not Provided
Principal Investigator: Daniel J Lee, MD, FACS MEEI, HMS, MGH
Massachusetts Eye and Ear Infirmary
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP