Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT04557618
Status:
RECRUITING
Last Update Posted:
2025-01-14
First Post:
2020-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Auricular VNS Following Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All participants will be fitted with an auricular stimulator, but blinded to whether they are receiving stimulation or not. Outcome scores will be assessed and recorded by clinicians blinded to treatment arm.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to either stimulation or sham stimulation arms'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-11', 'studyFirstSubmitDate': '2020-09-04', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammatory markers in the serum on admission', 'timeFrame': 'On hospital day 1', 'description': 'TNF alpha from blood draw'}, {'measure': 'Change in inflammatory markers in the serum', 'timeFrame': 'Through hospital admission, average of 4 weeks', 'description': 'TNF alpha from blood draws'}, {'measure': 'Inflammatory markers in the CSF on admission', 'timeFrame': 'On hospital day 1', 'description': 'TNF alpha from cerebrospinal fluid'}, {'measure': 'Change in inflammatory markers in the CSF', 'timeFrame': 'Through hospital admission, average of 4 weeks', 'description': 'TNF alpha from cerebrospinal fluid'}, {'measure': 'Cerebral vasospasm', 'timeFrame': 'Through hospital admission, average of 4 weeks', 'description': 'Presence of moderate/severe radiographic vasospasm'}, {'measure': 'Hydrocephalus', 'timeFrame': 'Through hospital admission, average of 4 weeks', 'description': 'Need for permanent CSF diversion via a ventricular shunt'}], 'secondaryOutcomes': [{'measure': 'Inflammatory markers in the serum on admission', 'timeFrame': 'On hospital day 1', 'description': 'IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8from blood draws'}, {'measure': 'Change in inflammatory markers in the serum', 'timeFrame': 'Through hospital admission, average of 4 weeks', 'description': 'IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8 from blood draws'}, {'measure': 'Inflammatory markers in the CSF on admission', 'timeFrame': 'On hospital day 1', 'description': 'IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8, from cerebrospinal fluid'}, {'measure': 'Change in inflammatory markers in the CSF', 'timeFrame': 'Through hospital admission, average of 4 weeks', 'description': 'IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8, from cerebrospinal fluid'}, {'measure': 'Cerebral vasospasm', 'timeFrame': 'Through hospital admission, average of 4 weeks', 'description': 'Additional features of vasospasm: 1) Number of vascular studies obtained, 2) Need for blood pressure augmentation or hypervolemia, 3) Need for intraarterial or intrathecal vasodilator, 4) Need for angioplasty'}, {'measure': 'Cerebral ischemia', 'timeFrame': 'Through hospital admission, average of 4 weeks', 'description': 'Presence of cerebral ischemia based on the following criteria: Radiographic evidence of a new infarct or stroke'}, {'measure': 'Hydrocephalus', 'timeFrame': 'Through hospital admission, average of 4 weeks', 'description': 'Duration of temporary CSF diversion via an external ventricular drain'}, {'measure': 'Clinical outcome', 'timeFrame': '2 years', 'description': 'Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)'}, {'measure': 'Stressed-induced cardiomyopathy', 'timeFrame': 'Through hospital admission, average of 4 weeks', 'description': 'Presence of stressed-induced cardiomyopathy based on any of the following criteria: 1) New troponin elevation, 2) New EKG changes (specifically ST segment elevation, ST segment depression, left bundle branch block, prolonged QT interval), 3) New findings of cardiomyopathy on echocardiogram'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vagal nerve stimulation'], 'conditions': ['Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '39786346', 'type': 'DERIVED', 'citation': 'Tan G, Huguenard AL, Donovan KM, Demarest P, Liu X, Li Z, Adamek M, Lavine K, Vellimana AK, Kummer TT, Osbun JW, Zipfel GJ, Brunner P, Leuthardt EC. The effect of transcutaneous auricular vagus nerve stimulation on cardiovascular function in subarachnoid hemorrhage patients: A randomized trial. Elife. 2025 Jan 9;13:RP100088. doi: 10.7554/eLife.100088.'}, {'pmid': '39178291', 'type': 'DERIVED', 'citation': 'Huguenard A, Tan G, Johnson G, Adamek M, Coxon A, Kummer T, Osbun J, Vellimana A, Limbrick D Jr, Zipfel G, Brunner P, Leuthardt E. Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH): Protocol for a prospective, triple-blinded, randomized controlled trial. PLoS One. 2024 Aug 23;19(8):e0301154. doi: 10.1371/journal.pone.0301154. eCollection 2024.'}, {'pmid': '38746275', 'type': 'DERIVED', 'citation': 'Huguenard AL, Tan G, Rivet DJ, Gao F, Johnson GW, Adamek M, Coxon AT, Kummer TT, Osbun JW, Vellimana AK, Limbrick DD, Zipfel GJ, Brunner P, Leuthardt EC. Auricular Vagus Nerve Stimulation Mitigates Inflammation and Vasospasm in Subarachnoid Hemorrhage: A Randomized Trial. medRxiv [Preprint]. 2024 May 1:2024.04.29.24306598. doi: 10.1101/2024.04.29.24306598.'}, {'pmid': '38633771', 'type': 'DERIVED', 'citation': 'Tan G, Huguenard AL, Donovan KM, Demarest P, Liu X, Li Z, Adamek M, Lavine K, Vellimana AK, Kummer TT, Osbun JW, Zipfel GJ, Brunner P, Leuthardt EC. The effect of transcutaneous auricular vagus nerve stimulation on cardiovascular function in subarachnoid hemorrhage patients: a safety study. medRxiv [Preprint]. 2024 Sep 8:2024.04.03.24304759. doi: 10.1101/2024.04.03.24304759.'}, {'pmid': '38562875', 'type': 'DERIVED', 'citation': 'Huguenard AL, Tan G, Johnson GW, Adamek M, Coxon AT, Kummer TT, Osbun JW, Vellimana AK, Limbrick DD Jr, Zipfel GJ, Brunner P, Leuthardt EC. Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH): Protocol for a prospective, triple-blinded, randomized controlled trial. medRxiv [Preprint]. 2024 Mar 19:2024.03.18.24304239. doi: 10.1101/2024.03.18.24304239.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following spontaneous subarachnoid hemorrhage.', 'detailedDescription': "Vagal nerve stimulation (VNS) has been studied in several inflammatory conditions, and has been implemented in animal models of subarachnoid hemorrhage (SAH) with promising results. The purpose of the proposed study is to determine how applying auricular VNS in patients presenting with spontaneous SAH impacts their expression of inflammatory markers in their blood and cerebrospinal fluid (CSF), and how it impacts their clinical course and outcomes.\n\nThis study will involve randomizing patients to stimulation with VNS, or sham stimulation. Blood and CSF will be collected on admission, and serially throughout the patient's admission. Clinical events tracked during the hospital stay include development of cerebral vasospasm, need for CSF diversion via a shunt, stress-induced cardiomyopathy, and development of stroke or global cerebral ischemia. Outcomes following admission will include functional scores at discharge, and at follow-up visits for up to 2 years after discharge."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spontaneous subarachnoid hemorrhage\n\nExclusion Criteria:\n\n* Trauma-induced subarachnoid hemorrhage\n* Ongoing chemotherapy\n* Taking immunosuppressive medications for other medical illnesses\n* Presence of a pacemaker\n* Prolonged bradycardia at time of admission'}, 'identificationModule': {'nctId': 'NCT04557618', 'briefTitle': 'Auricular VNS Following Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': '202007034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Auricular VNS Stimulation', 'description': 'Participants receive twice daily auricular vagal nerve stimulation', 'interventionNames': ['Device: Auricular Vagus Nerve Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Auricular VNS Stimulation', 'description': 'Participants will have an auricular vagal nerve stimulator applied twice daily, without the stimulation applied', 'interventionNames': ['Device: Sham Auricular Vagus nerve Stimulation']}], 'interventions': [{'name': 'Auricular Vagus Nerve Stimulation', 'type': 'DEVICE', 'description': 'Transcutaneous auricular vagal nerve stimulation', 'armGroupLabels': ['Auricular VNS Stimulation']}, {'name': 'Sham Auricular Vagus nerve Stimulation', 'type': 'DEVICE', 'description': 'Transcutaneous auricular vagal nerve ear clip applied without current', 'armGroupLabels': ['Sham Auricular VNS Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anna Huguenard, MD', 'role': 'CONTACT', 'email': 'ahuguenard@wustl.edu', 'phone': '3144506698'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Anna L Huguenard, MD', 'role': 'CONTACT', 'email': 'ahuguenard@wustl.edu', 'phone': '3144506698'}], 'overallOfficials': [{'name': 'Eric C Leuthardt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anna Huguenard', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident Physician', 'investigatorFullName': 'Anna Huguenard', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}