Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-02-28 @ 8:19 AM
Study NCT ID:
NCT04126408
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2019-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
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This will be compared to the sham device, which is the same device which will not provide stimulation to the nerve. Stimulation frequency will be identical to the frequency used in previous nVNS studies for the treatment of migraine headache.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 5, 'seriousNumAtRisk': 21, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Group', 'description': 'Active gammaCore device that supplies non-invasive stimulation of the cervical branch of the Vagus nerve\n\ngammaCore: The intervention consists of a transcutaneous non-invasive stimulation of the cervical branch of the vagus nerve (nVNS) using gammaCore, an FDA approved device for the treatment of migraine and cluster headache. This will be compared to the sham device, which is the same device which will not provide stimulation to the nerve. Stimulation frequency will be identical to the frequency used in previous nVNS studies for the treatment of migraine headache.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 9, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'site discomfort', 'notes': 'discomfort during stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'tingling sensation', 'notes': 'tingling during stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'pain at stimulation', 'notes': 'pain during stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'muscle twitching', 'notes': 'twitching during stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'transient facial droop', 'notes': 'during stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'dizziness', 'notes': 'dizziness during stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'hoarseness', 'notes': 'transient hoarseness during stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'dysgusia', 'notes': 'dysgusia during stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'dyspnea', 'notes': 'transient dyspnea during stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'nausea', 'notes': 'nausea during stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'coughing', 'notes': 'coughing during stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'hoarseness', 'notes': 'hoarseness during stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Difference Between the Active and Sham Treatment Groups in Morphine Equivalence Dosage PER DAY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Device', 'description': 'received stimulation'}, {'id': 'OG001', 'title': 'Sham', 'description': 'did not receive real stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.058', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'up to 14 days of admission', 'description': 'Daily morphine equivalence dosage will be calculated and compared between the active and Sham group', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '4O PARTICIPANTS , 19 IN ACTIVE GROUP AND 21 IN SHAM GROUP'}, {'type': 'PRIMARY', 'title': 'Overall Difference in MED at 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Device', 'description': 'received stimulation'}, {'id': 'OG001', 'title': 'Sham', 'description': 'did not receive real stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '21.99', 'spread': '21.41', 'groupId': 'OG000'}, {'value': '24.29', 'spread': '14.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 7 days', 'description': 'difference in mean morphine equivalent dosage at 7 days between active and sham group', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Difference Between the Active and Sham Treatment Groups in the Mean Daily Headache Intensity Pre and Post Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTIVE DEVICE', 'description': 'ACTIVE'}, {'id': 'OG001', 'title': 'Sham', 'description': 'did not receive stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.59', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'up to 14 days of admission', 'description': 'Headache intensity is measured every 4 hours per standard of care. The pain intensity is reported using a 0 to 10 numeric rating scale, o being no pain, and 10 being severe pain. least mean square difference between the 2 groups between the pre and post stimulation pain score', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '40, 19 ACtIVE AND 21 SHAM'}, {'type': 'SECONDARY', 'title': 'The Difference in Device Related Heart Rate Change Before and After Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACTIVE GROUP', 'description': 'received stimulation'}, {'id': 'OG001', 'title': 'Sham', 'description': 'no stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.73', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-0.76', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'up to 14 days of admission', 'description': 'difference in change in Heart rate between the 2 groups from before to after stimulation', 'unitOfMeasure': 'beats per min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'between sham and active hear rate'}, {'type': 'SECONDARY', 'title': 'Change in SBP Between Active and Sham Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active', 'description': 'active VNS group'}, {'id': 'OG001', 'title': 'Sham', 'description': 'sham group ( no real stimulation)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.20', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-1.64', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'before and after stimulation, up to 14 days', 'description': 'difference between pre and post stimulation SBP between the 2 groups', 'unitOfMeasure': 'millimeters of mercury', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham Arm', 'description': 'gammaCore sham device which will not provide stimulation of the vagus nerve\n\ngammaCore: The intervention consists of a transcutaneous non-invasive stimulation of the cervical branch of the vagus nerve (nVNS) using gammaCore, an FDA approved device for the treatment of migraine and cluster headache. This will be compared to the sham device, which is the same device which will not provide stimulation to the nerve. Stimulation frequency will be identical to the frequency used in previous nVNS studies for the treatment of migraine headache.'}, {'id': 'FG001', 'title': 'Treatment Group', 'description': 'Active gammaCore device that supplies non-invasive stimulation of the cervical branch of the Vagus nerve\n\ngammaCore: The intervention consists of a transcutaneous non-invasive stimulation of the cervical branch of the vagus nerve (nVNS) using gammaCore, an FDA approved device for the treatment of migraine and cluster headache. This will be compared to the sham device, which is the same device which will not provide stimulation to the nerve. 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MEANS THIN BLOOD WITH NO IVH\n2. MEANS THIN BLOOD WITH IVH\n3. MEANS THICK CLOOD WITH IVH\n4. MEANS THICK BLOOD WITH IVH THE HIGHEST THE mFS the more blood there'}, {'title': 'HHS', 'classes': [{'title': 'hhs1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'hhs2', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'hhs3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'hhs4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Hunt Hess Scale Is a prognostic scale, how the patient presented on admission, the higher the scare the poorer the prognosis HHS1. no/mild headache HHS2, mod/seve headache, CN palsy HHS3, drowsy, min neuron deficit HHS4 Stupor,mod/sev hemiparesis HHS5- Deep coma, decerebrate', 'unitOfMeasure': 'participants', 'populationDescription': '40 overall , 21 in sham and 19 in active'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-12', 'size': 697975, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-06T09:51', 'hasProtocol': True}, {'date': '2022-05-01', 'size': 192707, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-15T09:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-06', 'studyFirstSubmitDate': '2019-09-13', 'resultsFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2019-10-13', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-06', 'studyFirstPostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Difference Between the Active and Sham Treatment Groups in Morphine Equivalence Dosage PER DAY', 'timeFrame': 'up to 14 days of admission', 'description': 'Daily morphine equivalence dosage will be calculated and compared between the active and Sham group'}, {'measure': 'Overall Difference in MED at 7 Days', 'timeFrame': 'baseline and 7 days', 'description': 'difference in mean morphine equivalent dosage at 7 days between active and sham group'}], 'secondaryOutcomes': [{'measure': 'The Difference Between the Active and Sham Treatment Groups in the Mean Daily Headache Intensity Pre and Post Stimulation', 'timeFrame': 'up to 14 days of admission', 'description': 'Headache intensity is measured every 4 hours per standard of care. The pain intensity is reported using a 0 to 10 numeric rating scale, o being no pain, and 10 being severe pain. least mean square difference between the 2 groups between the pre and post stimulation pain score'}, {'measure': 'The Difference in Device Related Heart Rate Change Before and After Stimulation', 'timeFrame': 'up to 14 days of admission', 'description': 'difference in change in Heart rate between the 2 groups from before to after stimulation'}, {'measure': 'Change in SBP Between Active and Sham Group', 'timeFrame': 'before and after stimulation, up to 14 days', 'description': 'difference between pre and post stimulation SBP between the 2 groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Subarachnoid Hemorrhage, Aneurysmal']}, 'referencesModule': {'references': [{'pmid': '23808965', 'type': 'BACKGROUND', 'citation': 'Magalhaes JE, Azevedo-Filho HR, Rocha-Filho PA. The risk of headache attributed to surgical treatment of intracranial aneurysms: a cohort study. Headache. 2013 Nov-Dec;53(10):1613-23. doi: 10.1111/head.12165. Epub 2013 Jun 28.'}, {'pmid': '29107164', 'type': 'BACKGROUND', 'citation': 'Rumalla K, Smith KA, Arnold PM, Mittal MK. Subarachnoid Hemorrhage and Readmissions: National Rates, Causes, Risk Factors, and Outcomes in 16,001 Hospitalized Patients. World Neurosurg. 2018 Feb;110:e100-e111. doi: 10.1016/j.wneu.2017.10.089. Epub 2017 Oct 26.'}, {'pmid': '26932915', 'type': 'BACKGROUND', 'citation': 'Glisic EK, Gardiner L, Josti L, Dermanelian E, Ridel S, Dziodzio J, McCrum B, Enos B, Lerwick P, Fraser GL, Muscat P, Riker RR, Ecker R, Florman J, Seder DB. Inadequacy of Headache Management After Subarachnoid Hemorrhage. Am J Crit Care. 2016 Mar;25(2):136-43. doi: 10.4037/ajcc2016486.'}, {'pmid': '27704534', 'type': 'BACKGROUND', 'citation': 'Morad AH, Tamargo RJ, Gottschalk A. The Longitudinal Course of Pain and Analgesic Therapy Following Aneurysmal Subarachnoid Hemorrhage: A Cohort Study. Headache. 2016 Nov;56(10):1617-1625. doi: 10.1111/head.12908. Epub 2016 Oct 5.'}, {'pmid': '19828484', 'type': 'BACKGROUND', 'citation': 'Dorhout Mees SM, Bertens D, van der Worp HB, Rinkel GJ, van den Bergh WM. Magnesium and headache after aneurysmal subarachnoid haemorrhage. J Neurol Neurosurg Psychiatry. 2010 May;81(5):490-3. doi: 10.1136/jnnp.2009.181404. Epub 2009 Oct 13.'}, {'pmid': '24530613', 'type': 'BACKGROUND', 'citation': 'Oshinsky ML, Murphy AL, Hekierski H Jr, Cooper M, Simon BJ. Noninvasive vagus nerve stimulation as treatment for trigeminal allodynia. Pain. 2014 May;155(5):1037-1042. doi: 10.1016/j.pain.2014.02.009. Epub 2014 Feb 14.'}, {'pmid': '28286178', 'type': 'BACKGROUND', 'citation': 'Akerman S, Simon B, Romero-Reyes M. Vagus nerve stimulation suppresses acute noxious activation of trigeminocervical neurons in animal models of primary headache. Neurobiol Dis. 2017 Jun;102:96-104. doi: 10.1016/j.nbd.2017.03.004. Epub 2017 Mar 9.'}, {'pmid': '28104084', 'type': 'BACKGROUND', 'citation': 'Frangos E, Komisaruk BR. Access to Vagal Projections via Cutaneous Electrical Stimulation of the Neck: fMRI Evidence in Healthy Humans. Brain Stimul. 2017 Jan-Feb;10(1):19-27. doi: 10.1016/j.brs.2016.10.008. Epub 2016 Oct 20.'}, {'pmid': '20437558', 'type': 'BACKGROUND', 'citation': 'Bosche B, Graf R, Ernestus RI, Dohmen C, Reithmeier T, Brinker G, Strong AJ, Dreier JP, Woitzik J; Members of the Cooperative Study of Brain Injury Depolarizations (COSBID). Recurrent spreading depolarizations after subarachnoid hemorrhage decreases oxygen availability in human cerebral cortex. Ann Neurol. 2010 May;67(5):607-17. doi: 10.1002/ana.21943.'}, {'pmid': '26645547', 'type': 'BACKGROUND', 'citation': 'Chen SP, Ay I, Lopes de Morais A, Qin T, Zheng Y, Sadeghian H, Oka F, Simon B, Eikermann-Haerter K, Ayata C. Vagus nerve stimulation inhibits cortical spreading depression. Pain. 2016 Apr;157(4):797-805. doi: 10.1097/j.pain.0000000000000437.'}, {'pmid': '14571320', 'type': 'BACKGROUND', 'citation': 'Pavlov VA, Wang H, Czura CJ, Friedman SG, Tracey KJ. The cholinergic anti-inflammatory pathway: a missing link in neuroimmunomodulation. Mol Med. 2003 May-Aug;9(5-8):125-34.'}, {'pmid': '30943885', 'type': 'BACKGROUND', 'citation': 'Suzuki T, Takizawa T, Kamio Y, Qin T, Hashimoto T, Fujii Y, Murayama Y, Patel AB, Ayata C. Noninvasive Vagus Nerve Stimulation Prevents Ruptures and Improves Outcomes in a Model of Intracranial Aneurysm in Mice. Stroke. 2019 May;50(5):1216-1223. doi: 10.1161/STROKEAHA.118.023928.'}, {'pmid': '20633378', 'type': 'BACKGROUND', 'citation': 'George MS, Ward HE Jr, Ninan PT, Pollack M, Nahas Z, Anderson B, Kose S, Howland RH, Goodman WK, Ballenger JC. A pilot study of vagus nerve stimulation (VNS) for treatment-resistant anxiety disorders. Brain Stimul. 2008 Apr;1(2):112-21. doi: 10.1016/j.brs.2008.02.001. Epub 2008 Mar 28.'}, {'pmid': '29593576', 'type': 'BACKGROUND', 'citation': 'Breit S, Kupferberg A, Rogler G, Hasler G. Vagus Nerve as Modulator of the Brain-Gut Axis in Psychiatric and Inflammatory Disorders. Front Psychiatry. 2018 Mar 13;9:44. doi: 10.3389/fpsyt.2018.00044. eCollection 2018.'}, {'pmid': '30214271', 'type': 'BACKGROUND', 'citation': 'Lendvai IS, Maier A, Scheele D, Hurlemann R, Kinfe TM. Spotlight on cervical vagus nerve stimulation for the treatment of primary headache disorders: a review. J Pain Res. 2018 Aug 27;11:1613-1625. doi: 10.2147/JPR.S129202. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'This is a single site, randomized, sham-controlled, double blinded pilot study assessing the feasibility, safety, tolerability, and efficacy of non-invasive VNS (nVNS), gammaCore, in the treatment of headache in subarachnoid hemorrhage (SAH). 40 participants will be enrolled, 20 in the active device arm and 20 in the sham arm. The primary efficacy outcome is the the difference between the active and sham treatment groups in morphine equivalence dosage.', 'detailedDescription': "This is a single site, randomized, sham-controlled, double-blind study assessing the feasibility, safety, tolerability, and efficacy of non-invasive VNS (nVNS) in the treatment of headache in subarachnoid hemorrhage (SAH). The hypothesis is that two-two minute noninvasive stimulations of the cervical branch of the Vagus nerve, every 5 hours, is efficacious in safely reducing headache intensity and frequency in patients with headache due to SAH, during the patient's intensive care unit (ICU) stay. After screening and obtaining informed consent, eligible patients diagnosed with SAH on head scans, admitted to the Neurosurgical Intensive Care Unit (NSCU) at Northshore University Hospital will be randomized to either the treatment (stimulation of the cervical branch of the Vagus nerve) or sham (inactive stimulation) group. Pain intensity will be evaluated every 4 hours. Non-invasive stimulation will be performed every 5 hours. Device related adverse events, mean headache intensity, and mean and peak morphine equivalence dosage during the study period will be compared between the VNS group and the sham group.\n\nThe primary objective of this study is to examine the safety and effectiveness of nVNS as a treatment for headache in subarachnoid hemorrhage (SAH).\n\nThe primary safety endpoint for this study is the incidence of device related serious adverse events.\n\nThe primary outcome measurements for effectiveness is the difference between the active and sham treatment groups in morphine equivalence dosage\n\nSecondary endpoints include descriptive comparisons between the active and sham treatment groups in:\n\n* The difference between the active and sham treatment groups in the mean daily headache intensity\n* The difference between total overall morphine equivalence dosage between the active and sham group per subject during study\n* Opiate related adverse events (such as urinary retention, constipation, sedation, respiratory depression, nausea, vomiting and pruritis)\n* The difference in CSF and blood inflammatory markers before and after VNS\n* Difference in vessel diameter during angiogram for cerebral vasospasm before and after VNS\n\nStudy period is 14 days starting 24-72 hours post successful treatment of the aneurysm and extubation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established signed and dated informed consent form\n* CT of the head revealing blood in the subarachnoid space\n* Subject is male or female, 18 to 80 years of age\n* Subject alert to be able to verbalize pain level. If alertness improves after placement of an external ventricular drain, or once extubated, and the patient becomes alert , the patient will be enrolled\n* Subject reports pain of \\> =7 on 10 Point Pain numeric rating scale\n* Female of reproductive age must have a negative pregnancy test (Urine or blood test)\n\nExclusion Criteria:\n\n* Use of any concomitant electrostimulation devices (Pacemaker, defibrillator, deep brain stimulation.)\n* Unsecured aneurysm defined as aneurysm that has not been surgically or endovascularly treated.\n* Previous carotid surgeries or known history of carotid artery disease\n* Screws, metals or device in the neck\n* History of secondary or tertiary heart blocks, ventricular tachycardia, Supra-Ventricular Tachycardia (including atrial fibrillation)\n* Alcoholics (CAGE scale of 2 or greater). If patients are on Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol for alcohol withdrawal, the patient will be excluded from the study.\n* Drug addicts or chronic opioid users confirmed by history or with urine toxicology showing opiates or cocaine\n* small traumatic SAH'}, 'identificationModule': {'nctId': 'NCT04126408', 'acronym': 'VANQUISH', 'briefTitle': 'Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': '19-0837'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham arm', 'description': 'gammaCore sham device which will not provide stimulation of the vagus nerve', 'interventionNames': ['Device: gammaCore']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group', 'description': 'Active gammaCore device that supplies non-invasive stimulation of the cervical branch of the Vagus nerve', 'interventionNames': ['Device: gammaCore']}], 'interventions': [{'name': 'gammaCore', 'type': 'DEVICE', 'description': 'The intervention consists of a transcutaneous non-invasive stimulation of the cervical branch of the vagus nerve (nVNS) using gammaCore, an FDA approved device for the treatment of migraine and cluster headache. This will be compared to the sham device, which is the same device which will not provide stimulation to the nerve. Stimulation frequency will be identical to the frequency used in previous nVNS studies for the treatment of migraine headache.', 'armGroupLabels': ['Sham arm', 'Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northshore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, MD', 'investigatorFullName': 'Tania Rebeiz', 'investigatorAffiliation': 'Northwell Health'}}}}