Auditory Brainstem Implant (ABI) in Pediatric Non-Neurofibromatosis Type 2 Subjects (ABI)
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|ClinicalTrials.gov Identifier: NCT01864291|
Recruitment Status : Terminated (Closed by IRB)
First Posted : May 29, 2013
Results First Posted : May 19, 2020
Last Update Posted : June 2, 2020
|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)|
|Actual Enrollment :||9 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|
|Actual Primary Completion Date :||April 25, 2019|
|Actual Study Completion Date :||April 25, 2019|
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
- Number of Participants With Major or Minor ABI Complications [ Time Frame: 1 year 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.
- Change in Pure Tone Threshold (dB HL) Using the ABI [ Time Frame: 1-4 years from date of surgery ]
We will complete audiometric threshold testing and speech based tests to determine performance before and after ABI surgery.
The measure data value was calculated as mean threshold shift in dB HL from pre-surgery (or baseline) to postoperatively (following activation of the ABI) across subjects analyzed. Only those subjects that had auditory perception abilities were included. 2/9 subjects did not have auditory perception and are not using their devices.
The outcome measure time frame varies across subjects based on available followup data as this study was stopped early.
Audiometric testing will include:
• Behavioral pure tone threshold average (PTA) in both aided (with ABI) and unaided (without ABI)
- Number of Participants With Similar eABR Morphology on the Day of ABI Activation Compared to Intraoperative Responses [ Time Frame: 4 to 8 weeks after surgery (day of activation under anesthesia) ]
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. By following these measures, we will be able to capture how electrophysiologic parameters vary (if at all) over time.
The outcome measure data are the number of subjects whose eABR morphology was similar on the day of activation (4 to 8 weeks following surgery) as recorded intraoperatively during ABI surgery.
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|