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| Name | Class |
|---|---|
| University of Southern California | OTHER |
| Children's Hospital Los Angeles | OTHER |
| Huntington Medical Research Institutes | OTHER |
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Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities, are limited and, in the case of absent cochleas, non-existent. An auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study to determine the safety of the ABI.
The multichannel auditory brainstem implant (ABI) has now been used with some benefit in more than 1000 deaf patients worldwide who were not candidates for a cochlear implant (CI). For many years, the ABI was used primarily in adults deafened by Neurofibromatosis-Type 2 (NF2). During the past decade, ABI surgery has been safely performed on non-NF2 children outside of the United States, and results have shown great promise. The overall objective of this Phase I Clinical Trial grant is to evaluate safety in ten pediatric subjects who are not candidates for traditional cochlear implants due to cochlear nerve deficiency, cochlear aplasia, or cochlear ossification. These types of pathologies prevent normal transmission of auditory information between the cochlea and the brainstem. The University of Southern California, House Clinic, and Children's Hospital of Los Angeles are conducting a pediatric, non-NF2 ABI clinical with the Nucleus ABI device.
The Primary Aim is to describe the safety aspects of device implant surgery and 12-month use of an ABI in 10 pediatric patients (ages 2-6 years) with profound bilateral hearing loss not amenable to other treatments, such as hearing aids or cochlear implants. Surgical safety analysis is defined as no greater number of serious surgery-related adverse events than is commonly observed in non-NF2 adults undergoing craniotomy with or without an ABI and no more than four unexpected serious device-related adverse events for the 10 subjects during 12 months of follow-up. A Secondary Aim will determine whether or not the device provides patients with access to sound (thresholds of 50 dB HL) during a critical period for communication skills development. Efficacy is here defined as access to sound at a level and within the frequency range, known to be associated with speech.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Device Implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auditory Brainstem Implant | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | Surgical Safety The number of subjects successfully implanted. | 12-months post-device (auditory brainstem implant) successful activation |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint: Preliminary Efficacy | Access to sound at a level (dB HL) and with the frequency range (500-4000Hz), known to be associated with speech. | 3 years post-device activation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurie S. Eisenberg, PhD | Keck School of Medicine of USC | Principal Investigator |
| Eric Wilkinson, MD | Huntington Medical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck School of Medicine of USC | Los Angeles | California | 90008 | United States | ||
| Children's Hospital Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26366332 | Result | Fisher LM, Eisenberg LS, Krieger M, Wilkinson EP, Shannon RV; Los Angeles Pediatric ABI Team. Regulatory and funding strategies to develop a safety study of an auditory brainstem implant in young children who are deaf. Ther Innov Regul Sci. 2015 Sep;49(5):659-665. doi: 10.1177/2168479015599559. No abstract available. | |
| 27898605 | Result |
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Of the 10 subjects enrolled, 4 subjects did not proceed to auditory brainstem implant surgery because (1) the parents chose not to proceed, and/or (2) the child did not meet one or more of the inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Auditory Brainstem Implant | Visit # 1 2 3 4 5 6 7 8 9 10 11-12 Day 0 Day 1-4 Wk 1 Wk 4-6 M 1 M 3 M 6 M 9 M 12 Yr 2-3 Activity Screen Implant In-hospital Activate device Device Fitting/Evaluation Early Efficacy Informed consent X Medical History X Audiological tests X Psychological tests X Vital signs X X X X Physical examination X Chest x-ray, EKG X Vaccinations X CT and MRI X Laboratory tests X Neurotology exam X X X X EABR X X Soundfield Thresholds X X X X X X Monitor vital signs X X X X X X X Device Fitting ("Mapping") X X X X X X X IT-MAIS/MAIS X X X X X X X Adverse Events X X X X X X X X X X Communication Battery X X |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 18, 2021 | Oct 18, 2021 |
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| Los Angeles |
| California |
| 90027 |
| United States |
| Wilkinson EP, Eisenberg LS, Krieger MD, Schwartz MS, Winter M, Glater JL, Martinez AS, Fisher LM, Shannon RV; Los Angeles Pediatric ABI Team. Initial Results of a Safety and Feasibility Study of Auditory Brainstem Implantation in Congenitally Deaf Children. Otol Neurotol. 2017 Feb;38(2):212-220. doi: 10.1097/MAO.0000000000001287. |
| 29714549 | Result | Fisher LM, Martinez AS, Richmond FJ, Krieger MD, Wilkinson EP, Eisenberg LS. Assessing the Benefit-Risk Profile for Pediatric Implantable Auditory Prostheses. Ther Innov Regul Sci. 2018 Sep;52(5):669-679. doi: 10.1177/2168479017741111. Epub 2017 Nov 29. |
| 29718280 | Result | Eisenberg LS, Hammes Ganguly D, Martinez AS, Fisher LM, Winter ME, Glater JL, Schrader DK, Loggins J, Wilkinson EP; Los Angeles Pediatric ABI Team. Early Communication Development of Children with Auditory Brainstem Implants. J Deaf Stud Deaf Educ. 2018 Jul 1;23(3):249-260. doi: 10.1093/deafed/eny010. |
| Auditory Brainstem Implant Surgery | Undergo auditory brainstem implant surgery |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Device Implantation Auditory Brainstem Implant |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | age at time of surgery or enrollment into the study | Mean | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Endpoint | Surgical Safety The number of subjects successfully implanted. | Deaf children receiving the auditory brainstem implant | Posted | Count of Participants | Participants | 12-months post-device (auditory brainstem implant) successful activation |
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| ||||||||||||||||||||||||||
| Secondary | Secondary Endpoint: Preliminary Efficacy | Access to sound at a level (dB HL) and with the frequency range (500-4000Hz), known to be associated with speech. | Posted | Count of Participants | Participants | 3 years post-device activation |
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3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Device Implantation Auditory Brainstem Implant | 1 | 10 | 1 | 10 | 1 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CSF leak following surgery resolved with lumbar drain | Ear and labyrinth disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vestibular effects during electricial stimulation. Resolved by deprogramming affected electrode. | Ear and labyrinth disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laurie Eisenberg | University of Southern California | 213-764-2826 | laurie.eisenberg@med.usc.edu |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D003638 | Deafness |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D038262 | Auditory Brain Stem Implants |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
| D006310 | Hearing Aids |
| D012682 | Sensory Aids |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Categories |
|---|
| 250 Hz |
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| 500 Hz |
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| 1000 Hz |
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| 2000 Hz |
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| 4000 Hz |
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