Trial Outcomes & Findings for Auditory Brainstem Implant (ABI) in Pediatric Non-Neurofibromatosis Type 2 Subjects (NCT NCT01864291)

Last Updated: 2020-06-02

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

1 year from date of surgery

Results posted on

2020-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Non-NF2 ABI Surgery Implantation with Auditory Brainstem Implant (ABI) device and clinical follow-up
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Non-NF2 ABI Surgery Implantation with Auditory Brainstem Implant (ABI) device and clinical follow-up
Overall Study need for revision surgery	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-NF2 ABI Surgery n=9 Participants Implantation with Auditory Brainstem Implant (ABI) device and clinical follow-up
Age, Categorical <=18 years	9 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=9 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants
Age, Continuous	27 months n=9 Participants
Sex: Female, Male Female	4 Participants n=9 Participants
Sex: Female, Male Male	5 Participants n=9 Participants
Region of Enrollment United States	9 participants n=9 Participants
Sound detection via pure-tone threshold audiometry	120 dB HL n=9 Participants

PRIMARY outcome

Timeframe: 1 year from date of surgery

Outcome measures

Outcome measures
Measure	Non-NF2 ABI Surgery n=9 Participants Implantation with Auditory Brainstem Implant (ABI) device and clinical follow-up
Number of Participants With Major or Minor ABI Complications Major Complications	2 Participants
Number of Participants With Major or Minor ABI Complications Minor Complications	7 Participants

SECONDARY outcome

Timeframe: 1-4 years from date of surgery

Population: 2/9 subjects required revision surgery for device issues and were not included in this analysis as they did not complete the study. An additional 2/9 subjects did not have auditory perception and are not using their device and were also not included in this analysis.

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)

Outcome measures

Outcome measures
Measure	Non-NF2 ABI Surgery n=5 Participants Implantation with Auditory Brainstem Implant (ABI) device and clinical follow-up
Change in Pure Tone Threshold (dB HL) Using the ABI	73 dB HL Interval 65.0 to 85.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Non-NF2 ABI Surgery n=9 Participants Implantation with Auditory Brainstem Implant (ABI) device and clinical follow-up
Number of Participants With Similar eABR Morphology on the Day of ABI Activation Compared to Intraoperative Responses	8 Participants

Adverse Events

Non-NF2 ABI Surgery

Serious events: 7 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Non-NF2 ABI Surgery n=9 participants at risk Implantation with Auditory Brainstem Implant (ABI) device and clinical follow-up
Product Issues device failure	33.3% 3/9 • Number of events 3 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
Product Issues no auditory perception	22.2% 2/9 • Number of events 2 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
Gastrointestinal disorders nausea and vomiting	22.2% 2/9 • Number of events 2 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
Respiratory, thoracic and mediastinal disorders oxygen desaturation	22.2% 2/9 • Number of events 2 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
Respiratory, thoracic and mediastinal disorders upper respiratory infection with shortness of breath	11.1% 1/9 • Number of events 1 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.

Other adverse events

Other adverse events
Measure	Non-NF2 ABI Surgery n=9 participants at risk Implantation with Auditory Brainstem Implant (ABI) device and clinical follow-up
Ear and labyrinth disorders ear infection	22.2% 2/9 • Number of events 2 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
Blood and lymphatic system disorders anemia	11.1% 1/9 • Number of events 1 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
Respiratory, thoracic and mediastinal disorders post-intubation airway edema	11.1% 1/9 • Number of events 1 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
Skin and subcutaneous tissue disorders blister	11.1% 1/9 • Number of events 1 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
Skin and subcutaneous tissue disorders abcess	11.1% 1/9 • Number of events 1 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
General disorders swelling after fall	11.1% 1/9 • Number of events 1 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
General disorders pain	11.1% 1/9 • Number of events 1 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
Respiratory, thoracic and mediastinal disorders upper respiratory infection	11.1% 1/9 • Number of events 1 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
General disorders postoperative edema	11.1% 1/9 • Number of events 1 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
Cardiac disorders bradycardia	11.1% 1/9 • Number of events 1 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
General disorders bruxism	11.1% 1/9 • Number of events 1 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.
Ear and labyrinth disorders ear drainage	11.1% 1/9 • Number of events 1 • Adverse events were collected up to 5 years post-operatively for purposes of the study, though all participants have ongoing routine safety monitoring as part of their clinical care.

Additional Information

Dr. Daniel Lee

Massachusetts Eye & Ear Infirmary

Phone: 6175736391

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place