Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-05 @ 1:49 PM
Study NCT ID:
NCT02102256
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2014-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003638', 'term': 'Deafness'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038262', 'term': 'Auditory Brain Stem Implants'}], 'ancestors': [{'id': 'D058117', 'term': 'Neural Prostheses'}, {'id': 'D058542', 'term': 'Implantable Neurostimulators'}, {'id': 'D004567', 'term': 'Electrodes, Implanted'}, {'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D006310', 'term': 'Hearing Aids'}, {'id': 'D012682', 'term': 'Sensory Aids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laurie.eisenberg@med.usc.edu', 'phone': '213-764-2826', 'title': 'Dr. Laurie Eisenberg', 'organization': 'University of Southern California'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental', 'description': 'Device Implantation\n\nAuditory Brainstem Implant', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Vestibular effects during electricial stimulation. Resolved by deprogramming affected electrode.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'CSF leak following surgery resolved with lumbar drain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Auditory Brainstem Implant', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12-months post-device (auditory brainstem implant) successful activation', 'description': 'Surgical Safety The number of subjects successfully implanted.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Deaf children receiving the auditory brainstem implant'}, {'type': 'SECONDARY', 'title': 'Secondary Endpoint: Preliminary Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Device Implantation Auditory Brainstem Implant'}], 'classes': [{'title': '250 Hz', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '500 Hz', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '1000 Hz', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '2000 Hz', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '4000 Hz', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years post-device activation', 'description': 'Access to sound at a level (dB HL) and with the frequency range (500-4000Hz), known to be associated with speech.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Auditory Brainstem Implant', 'description': '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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Auditory Brainstem Implant Surgery', 'comment': 'Undergo auditory brainstem implant surgery', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental', 'description': 'Device Implantation\n\nAuditory Brainstem Implant'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'MEAN', 'description': 'age at time of surgery or enrollment into the study', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2021-10-18', 'size': 207532, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-18T11:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2014-03-19', 'resultsFirstSubmitDate': '2022-10-18', 'studyFirstSubmitQcDate': '2014-03-28', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-25', 'studyFirstPostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoint', 'timeFrame': '12-months post-device (auditory brainstem implant) successful activation', 'description': 'Surgical Safety The number of subjects successfully implanted.'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoint: Preliminary Efficacy', 'timeFrame': '3 years post-device activation', 'description': 'Access to sound at a level (dB HL) and with the frequency range (500-4000Hz), known to be associated with speech.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['deafness', 'congenital', 'pediatric', 'device'], 'conditions': ['Profound Bilateral Deafness Due to', 'Bilateral Cochlear Aplasia', 'Bilateral Cochlear Nerve Deficiency', 'Bilateral Cochlear Ossification Secondary to Meningitis']}, 'referencesModule': {'references': [{'pmid': '26366332', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '27898605', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '29714549', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '29718280', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis\n* If previously received a cochlear implant, must demonstrate lack of benefit from that device\n\nExclusion Criteria:\n\n* Medical contraindication to craniotomy/intracranial surgery\n* Severe cognitive or developmental delays'}, 'identificationModule': {'nctId': 'NCT02102256', 'briefTitle': 'A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'A Feasibility Study of the Placement, Use, and Safety of the Nucleus 24 Auditory Brainstem Implant in Non-Neurofibromatosis Type 2 (NF2) Pediatric Patients', 'orgStudyIdInfo': {'id': 'KSOM-ABI 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Device Implantation', 'interventionNames': ['Device: Auditory Brainstem Implant']}], 'interventions': [{'name': 'Auditory Brainstem Implant', 'type': 'DEVICE', 'otherNames': ['Cochlear Corporation Nucleus 24'], 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90008', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck School of Medicine of USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Laurie S. Eisenberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keck School of Medicine of USC'}, {'name': 'Eric Wilkinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huntington Medical Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laurie Eisenberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern California', 'class': 'OTHER'}, {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, {'name': 'Huntington Medical Research Institutes', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Research Otolaryngology', 'investigatorFullName': 'Laurie Eisenberg', 'investigatorAffiliation': 'University of Southern California'}}}}