Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT03500718
Status:
COMPLETED
Last Update Posted:
2020-02-24
First Post:
2018-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], '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': 'D003054', 'term': 'Cochlear 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-20', 'studyFirstSubmitDate': '2018-04-02', 'studyFirstSubmitQcDate': '2018-04-15', 'lastUpdatePostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in threshold of ECAP after cochlear implantation.', 'timeFrame': 'during implantation, at switch on( 4 weeks), after 3months and 6months.', 'description': 'To evaluate changes in threshold of ECAP during cochlear implantation, at switch on( 4 weeks), after 3 months and 6 months following cochlear implantation.'}], 'secondaryOutcomes': [{'measure': 'Correlate the amplitude of ECAP with T & C levels.', 'timeFrame': '2 years', 'description': 'Correlating the amplitude of ECAP with threshold and comfortable levels and creating a MAP.'}, {'measure': 'Correlate amplitude of ECAP with cochlear nerve diameter measured pre-operatively.', 'timeFrame': '2 mins', 'description': 'By correlating amplitude of ECAP with cochlear nerve diameter we can determine the site to be operated preoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cochlear implant', 'threshold of electrically evoked compound action potential', 'neural response telemetry'], 'conditions': ['Cochlear Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '20634770', 'type': 'BACKGROUND', 'citation': "Kim JR, Abbas PJ, Brown CJ, Etler CP, O'Brien S, Kim LS. The relationship between electrically evoked compound action potential and speech perception: a study in cochlear implant users with short electrode array. Otol Neurotol. 2010 Sep;31(7):1041-8. doi: 10.1097/MAO.0b013e3181ec1d92."}, {'pmid': '27804133', 'type': 'BACKGROUND', 'citation': 'van Eijl RH, Buitenhuis PJ, Stegeman I, Klis SF, Grolman W. Systematic review of compound action potentials as predictors for cochlear implant performance. Laryngoscope. 2017 Feb;127(2):476-487. doi: 10.1002/lary.26154. Epub 2016 Nov 2.'}]}, 'descriptionModule': {'briefSummary': 'After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, after 4 weeks( at switch on), after 3months and 6 months following cochlear implantation.', 'detailedDescription': "After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, 4 weeks(at switch on) and after 3months and 6 months following cochlear implantation. Neural Response Telemetry (NRT) is a quick and non-invasive way of recording ECAP of the peripheral auditory nerves in-situ. It gives clinicians valuable information for programming the T- (Threshold) and C-(Comfort) - levels of the recipient's speech processor map. Intraoperative NRT in conjunction with electrode impedance data can help indicate the integrity of the implanted electrodes and the electrode/auditory nerve interface, confirming that the implant is functioning correctly intraoperatively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children between 1 and 6 years of age undergoing cochlear implantation in JIPMER during the study period.\n\nExclusion Criteria:\n\n* Incomplete electrode array insertion.'}, 'identificationModule': {'nctId': 'NCT03500718', 'briefTitle': 'Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Jawaharlal Institute of Postgraduate Medical Education & Research'}, 'officialTitle': 'Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation', 'orgStudyIdInfo': {'id': 'JIP/IEC/2017/0339'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pediatric patients with bilateral sensorineural hearing loss', 'description': 'One group will be studied: Patients undergoing cochlear implantation surgery between age 1 and 6 years who meet the above inclusion and exclusion criteria seen in JIPMER during the study period.', 'interventionNames': ['Device: Cochlear implant']}], 'interventions': [{'name': 'Cochlear implant', 'type': 'DEVICE', 'description': 'After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).', 'armGroupLabels': ['Pediatric patients with bilateral sensorineural hearing loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '605006', 'city': 'Puducherry', 'country': 'India', 'facility': 'JIPMER', 'geoPoint': {'lat': 11.93381, 'lon': 79.82979}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Confidentiality regarding patient's participation in the study will be maintained throughout the study period as well as after completion of the study."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jawaharlal Institute of Postgraduate Medical Education & Research', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'JUNIOR RESIDENT', 'investigatorFullName': 'Dr. Aparna Das', 'investigatorAffiliation': 'Jawaharlal Institute of Postgraduate Medical Education & Research'}}}}