Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-20 @ 11:40 AM
Study NCT ID:
NCT07025356
Status:
COMPLETED
Last Update Posted:
2025-06-17
First Post:
2025-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of the the Use of a Trigeminal Vagal Nerve Stimulator in the Routine Care of Native Americans With Diabetic Neuropathy Pain. Pain Scores, Drug Use and Glucose Measurements Will be Assessed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2025-06-09', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores over time', 'timeFrame': '90 days', 'description': 'Periodic pain scores will be measured for 90 days and possibly longer'}], 'secondaryOutcomes': [{'measure': 'glucose levels will be measured over time', 'timeFrame': '90 days', 'description': 'Serum glucose levels will be followed on patients receiving neurostimulation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Vagus', 'diabetic neuropathy', 'auricular', 'stimulation'], 'conditions': ['Diabetic Neuropathy With Neurologic Complication']}, 'descriptionModule': {'briefSummary': 'This is an observational study that will follow patients in the course of routine care and measure pain levels, glucose assessments and drug utilization for native American patients with diabetic neuropathy', 'detailedDescription': 'Patients with diabetic neuropathy pain will have an NS100 device implanted for chronic diabetic neuropathy pain consistent with onlabel indication. All patients will be followed for 90 days post implant to measure improvements in pain, drug utilization and glucose levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Native American Population with Diabetic Neuropathy pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic Neuropathy Pain History of failed treatment WIlling to follow blood glucose and pain scores for 90 days\n\nExclusion Criteria\n\n* Bleeding diathesis Pregnancy Cardiac monitoring device Implantable Neurostimulator Inability to give informed consedn'}, 'identificationModule': {'nctId': 'NCT07025356', 'briefTitle': 'Observational Study of the the Use of a Trigeminal Vagal Nerve Stimulator in the Routine Care of Native Americans With Diabetic Neuropathy Pain. Pain Scores, Drug Use and Glucose Measurements Will be Assessed', 'organization': {'class': 'OTHER', 'fullName': 'Vagus Nerve Society'}, 'officialTitle': 'Combined Minimally Invasive Vagal Cranial Nerve and Trigeminocervical Complex Peripheral Nerve Stimulation In Severe Painful Peripheral Neuropathy', 'orgStudyIdInfo': {'id': 'VNS 001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Native Americans with Diabetic Neuropathy Pain', 'description': 'Use of Trigeminal Vagus cervical nerve stimulation for diabetic neuropathy pain', 'interventionNames': ['Drug: Implantation of a trigeminal Vagus cervical nerve stimulator system', 'Device: Implantation of a neurostimulator system for trigeminal vagal cervical nerve stimulation']}], 'interventions': [{'name': 'Implantation of a trigeminal Vagus cervical nerve stimulator system', 'type': 'DRUG', 'description': 'The NS 100 is a medical device used for the treatment of diabetic neuropathy pain. Routine observational monitoring will be performed', 'armGroupLabels': ['Native Americans with Diabetic Neuropathy Pain']}, {'name': 'Implantation of a neurostimulator system for trigeminal vagal cervical nerve stimulation', 'type': 'DEVICE', 'description': 'The medium term outcomes of neurostimulation will be assessed on diabetic neuropathy pain, glucose and drug usage', 'armGroupLabels': ['Native Americans with Diabetic Neuropathy Pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57770', 'city': 'Pine Ridge', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Continuum of Care Clinic', 'geoPoint': {'lat': 43.02554, 'lon': -102.55627}}], 'overallOfficials': [{'name': 'Claire Marie Rangon, MD PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vagus Nerve Society'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Want to maintain patient autonomy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vagus Nerve Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}