Auditory Brainstem Implant (ABI) in Pediatric Non-Neurofibromatosis Type 2 Subjects (ABI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01864291|
Recruitment Status : Active, not recruiting
First Posted : May 29, 2013
Last Update Posted : November 9, 2018
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of the Nucleus 24 and ABI541 Auditory Brainstem Implants in Pediatric Non-Neurofibromatosis Type 2|
|Actual Study Start Date :||May 2013|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
Experimental: Non-NF2 ABI surgery
All subjects will be part of a single arm involving placement of the 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, ABI541, Nucleus Profile, Cochlear Americas
- ABI Complications [ Time Frame: 5 years from date of surgery ]We will track any major and minor complications peri-operatively and post-operatively in all study participants. Major complications include mortality, cerebellar contusion, facial palsy, meningitis, lower cranial neuropathy, hydrocephalus, pseudomeningocele and CSF leak. Minor complications include transient hydrocephalus, wound seroma, minor infections, balance problems, transient nerve palsies, transient dysphonia or difficulty swallowing, headache, flap problems, and non-auditory side effects. These complications will be tracked through serial clinical exams as well as patient recorded questionnaires to determine the safety profile of ABI surgery.
- Audiologic Performance with ABI [ Time Frame: 5 years from date of surgery ]
We will complete audiologic and speech based tests to determine performance before and after ABI surgery. In particular, pre- and post-operative behavioral audiometry and speech perception testing will be used.
Audiometric testing will include:
- Detection audiogram, aided and unaided individual ears
- IT-MAIS or MAIS
- LING 6 sound test (MLV)
- ESP Low Verbal or Standard-Recorded if possible or MLV @ 60dB HL
- PB-k words and phonemes- Recorded @ 60dB HL
- CNC- 50 words @ 65dB SPL
Speech and language assessment: MacArthur-Bates Communicative Development Inventories (CDIs) (56), Pre-School Language Scale, , Fourth Edition (PLS-5) Clinical Evaluation of Language Fundamentals Preschool, Second Edition (CELF-P2), Clinical Evaluation of Language Fundamentals, Fourth Edition (CELF-4), and the Goldman-Fristoe Test of Articulation.
- ABI Electrophysiologic Measures [ Time Frame: 5 years from date of surgery ]We will measure and record the specific programmed parameters of the ABI device. Intraoperatively, evoked Auditory Brainstem Response (eABRs) will be recorded and saved. These tracings and data will be compared to the settings on activation to determine whether the same electrodes are appropriately positioned. In addition, we will record stimulation thresholds for each electrode and track those parameters over time. By following these measure, we will be able to capture how electrophysiologic parameters vary (if at all) over time.
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): NCT01864291
|United States, Massachusetts|
|Massachusetts Eye and Ear Infirmary|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Daniel J Lee, MD FACS||MEEI/MGH|