Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-01-06 @ 10:00 AM
Study NCT ID:
NCT06491758
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-09', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-07-03', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitude of vagal nerve compound action', 'timeFrame': '3 hours', 'description': 'To measure the amplitude of vagal nerve compound action potentials during stimulation of the auricular branch of the vagal nerve and during vagal maneuvers.'}, {'measure': 'Respiratory Changes in heart rate during stimulation', 'timeFrame': '3 hours', 'description': 'To measure respiratory changes in heart rate during stimulation of the auricular branch of the vagal nerve and also during the vagal maneuvers phase.'}, {'measure': 'Changes in amplitude of the surface electrogastrogram', 'timeFrame': '3 hours.', 'description': 'To measure the changes of surface electrogastogram during stimulation of the auricular branch of the vagal nerve and also during the vagal maneuvers phase.'}, {'measure': 'Changes in gastric hormones', 'timeFrame': '3 hours.', 'description': 'To measure the effect of stimulation of the auricular branch of the vagal nerve and/or of vagal maneuvers on gastric hormones.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Gastroparesis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if we can gain access to the vagus nerve which is largely an internal nerve that controls stomach function. We hope to gain access to the internal vagus nerve by electrically stimulating the nerve around the external ear. If we can do this then we hope that this will help our treatment of patients with nausea and vomiting and disordered stomach function', 'detailedDescription': 'Subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve and also undergo blood draw before, after stimulation and later a third draw after a period of no stimulation. Healthy subjects will also undergo vagal maneuver using the Multi Array Electrodes (MEA). Gastroparetic subjects will also undergo vagal maneuver using either the regular EKG electrodes or the MEA electrodes.\n\nSubjects will also complete health history questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria healthy volunteers\n\n* Healthy volunteers with no gastric symptoms or conditions (except due to COVID 19)\n* Aged 18-80 years\n* Willing to have electrodes placed in the external ear (ABVN arm)\n* Willing to perform vagal activity maneuver (Vagal arm)\n* Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points\n\nInclusion Criteria gastroparesis subjects\n\n* Gastroparesis subjects with a confirmed diagnosis of gastroparesis from a GI physician\n* Have a formal diagnosis of gastroparesis or are seeing the GI physician for symptoms related to gastroparesis\n* Aged 18-80 years\n* Willing to have electrodes placed in the external ear (ABVN arm)\n* Willing to perform vagal activity maneuver (Vagal arm)\n* Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Pregnant females\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT06491758', 'acronym': 'ABVN2', 'briefTitle': 'ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials Phase 2', 'orgStudyIdInfo': {'id': '2006075899- A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Subjects', 'description': 'Subjects who have no gastric symptoms or conditions', 'interventionNames': ['Device: ML1101 Stimulus Isolator', 'Procedure: Vagal Maneuver']}, {'type': 'EXPERIMENTAL', 'label': 'Gastroparesis Subjects', 'description': 'Subjects with a confirmed diagnosis of gastroparesis.', 'interventionNames': ['Device: ML1101 Stimulus Isolator', 'Procedure: Vagal Maneuver']}], 'interventions': [{'name': 'ML1101 Stimulus Isolator', 'type': 'DEVICE', 'description': 'Electrical stimulation electrodes will be placed on the ear with the intensity of the current being increased by 10 percent every 60 seconds, the subject will grade the intensity of the current on a scale of 0-10. Increasing of the current will occur until the subject reports a comfortable level. Once the target level has been achieved the stimulation will be delivered for 2 minutes.', 'armGroupLabels': ['Gastroparesis Subjects', 'Healthy Subjects']}, {'name': 'Vagal Maneuver', 'type': 'PROCEDURE', 'description': 'Subjects will undergo the following procedures to stimulate the vagus nerve.\n\n* Cough: 6 to 8 forceful coughs\n* Cold stimulus: a washcloth soaked in ice water will be placed on the face for 10 seconds.\n* Carotid massage\n* Gagging: a tongue depressor will be inserted for 10 seconds into the mouth touching the back of the mouth.\n* Valsalva maneuver: subjects will will be asked to bear down as if they were having a bowel movement. They will be asked to blow through a mouthpiece that is hooked to a machine that measures how hard they are blowing.\n* Eating: Subjects will be asked to drink water ( 8oz or 1 cup) or/ and Ensure Original ( 8 oz or 1 cup) that has 220 calories after fasting overnight to see that effect on vagal activity during eating.', 'armGroupLabels': ['Gastroparesis Subjects', 'Healthy Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maureen Schilling, BS', 'role': 'CONTACT', 'email': 'maschi@iu.edu', 'phone': '317-278-2064'}, {'name': 'Lainna Cohen, MSW', 'role': 'CONTACT', 'email': 'larcohen@iu.edu', 'phone': '3172780621'}, {'name': 'John M Wo, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas V Nowak, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'centralContacts': [{'name': 'Maureen Schilling, BS', 'role': 'CONTACT', 'email': 'maschi@iu.edu', 'phone': '3172782064'}, {'name': 'Lainna Cohen, MSW', 'role': 'CONTACT', 'email': 'larcohen@iu.edu', 'phone': '3172780621'}], 'overallOfficials': [{'name': 'Thomas V Nowak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Three years after study completion', 'ipdSharing': 'YES', 'description': 'De-identified data may be shared with other researchers for similar purposes as to this study', 'accessCriteria': 'None as of yet.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Thomas V. Nowak', 'investigatorAffiliation': 'Indiana University'}}}}