Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-30 @ 2:39 PM
Study NCT ID:
NCT04668534
Status:
UNKNOWN
Last Update Posted:
2020-12-16
First Post:
2020-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-03-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-13', 'studyFirstSubmitDate': '2020-12-06', 'studyFirstSubmitQcDate': '2020-12-13', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Short Form of Nepean Dyspepsia Index (SF-NDI)', 'timeFrame': '4 weeks', 'description': 'The SF-NDI consists of 10 questions regarding the effects of dyspepsia symptoms ("stomach problems") on different aspects of life (tension, interference with daily activities, eating/drinking, knowledge/control, and work/study). Each response can be from 1 (not at all affected) to 5 (extremely affected), or 0 (N/A), for a total summed score out of 50.'}, {'measure': 'Hamilton Anxiety and Depression Scale', 'timeFrame': '4 weeks', 'description': 'Anxiety and depression of patients are assessed by using Hamilton Anxiety and Depression Scale.\n\nHamilton Anxiety Scale consists of 14 items. Each item is scored on a scale from 0 (absent) to 4 (most severe) with a total score range of 0-56.\n\nHamilton Depression Scale consists of 17 items. Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 52.'}, {'measure': 'Adverse event', 'timeFrame': '4 weeks'}], 'primaryOutcomes': [{'measure': 'Responder rate', 'timeFrame': '4 weeks', 'description': 'The proportion of patients whose Functional Dyspepsia Symptom Diary Total Symptom Scores were reduced ≥5 after four weeks treatment when compared with baseline.'}], 'secondaryOutcomes': [{'measure': 'Functional Dyspepsia Symptom Diary (FDSD)', 'timeFrame': '4 weeks', 'description': 'The FDSD consists of 5 cardinal items (burning in the stomach, stomach pain, bloating, postprandial fullness, and early satiety) and 3 supplementary items (nausea, burping/belching rating, and burping/belching bother). Each item can be scored from 0 (no) to 10 (worst). Total Symptom Score includes the 5 cardinal items and ranges from 0 to 50.'}, {'measure': 'Gastrointestinal Symptom Rating Scale (GSRS)', 'timeFrame': '4 weeks', 'description': 'The GSRS contains 15 items. All individual items are scored on a 7-point Likert scale (1 = not at all to 7 = extremely) and are subsequently clustered into five domains (abdominal pain, reflux, indigestion, diarrhea, and constipation); higher scores indicate more severe symptoms.'}, {'measure': 'Adequate relief rate', 'timeFrame': '4 weeks', 'description': 'The proportion of patients who acquire overall symptom relief when compared with baseline'}, {'measure': 'Elimination rate of cardinal symptom', 'timeFrame': '4 weeks', 'description': 'The proportion of patients whose cardinal symptom is completely eliminated when compared with baseline.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional Dyspepsia'], 'conditions': ['Functional Dyspepsia']}, 'referencesModule': {'references': [{'pmid': '37787432', 'type': 'DERIVED', 'citation': 'Shi X, Zhao L, Luo H, Deng H, Wang X, Ren G, Zhang L, Tao Q, Liang S, Liu N, Huang X, Zhang X, Yang X, Sun J, Qin W, Kang X, Han Y, Pan Y, Fan D. Transcutaneous Auricular Vagal Nerve Stimulation Is Effective for the Treatment of Functional Dyspepsia: A Multicenter, Randomized Controlled Study. Am J Gastroenterol. 2024 Mar 1;119(3):521-531. doi: 10.14309/ajg.0000000000002548. Epub 2023 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'Patients with dyspeptic symptoms vary from 10% to 20% globally. Up to 70% of patients with dyspepsia who undergo endoscopy have unremarkable examination and are diagnosed with functional dyspepsia (FD). Given the lack of information related to its pathophysiology, the treatment is largely empirical and of limited efficacy. Previous small study showed therapeutic potential of transcutaneous auricular vagal nerve stimulation (taVNS) for FD. This study aims to investigate whether taVNS can improve the dyspeptic symptoms of patients with FD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-65 years old\n2. Patients who met the Rome IV diagnostic criteria of FD\n3. Moderate to severe FD (functional dyspepsia symptom diary ≥10)\n4. Normal upper endoscopy and abdominal ultrasonography within one year.\n\nExclusion Criteria:\n\n1. Injury or inflammation on the ear\n2. Asthma or COPD not under control\n3. History of cardiac pacemaker planting or other medical digital devices\n4. History of VNS treatment\n5. Patients with local or systemic diseases which may cause dyspeptic symptoms:\n\n Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.; Known acute or chronic injury of liver or kidney; Obvious hematological abnormality, or endocrine and metabolic diseases; Known malignancy; Obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.; Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)\n6. Patients with serious mental disorders or tendency to suicide\n7. Pregnancy or lactic women\n8. Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT04668534', 'briefTitle': 'Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KY20202087-F-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group 1', 'description': 'Based on the infection of Hp or not, patients will receive quadruple therapy (amoxicillin, clarithromycin, pantoprazole, and bismuth) or PPI (pantoprazole) plus taVNS (produced by by Xi\'an Bashui Health Technology Co., Ltd) at left tragus. Patients were given taVNS thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs).', 'interventionNames': ['Device: taVNS 10']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group 2', 'description': 'Based on the infection of Hp or not, patients will receive quadruple therapy (amoxicillin, clarithromycin, pantoprazole, and bismuth) or PPI (pantoprazole) plus taVNS (produced by by Xi\'an Bashui Health Technology Co., Ltd) at left tragus. Patients were given taVNS thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 25 Hz; current intensity: minimal pain threshold; pulse width: 500 μs).', 'interventionNames': ['Device: taVNS 25']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Based on the infection of Hp or not, patients will receive quadruple therapy (amoxicillin, clarithromycin, pantoprazole, and bismuth) or PPI (pantoprazole) plus taVNS (produced by by Xi\'an Bashui Health Technology Co., Ltd) at left earlobe. Patients were given taVNS thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs).', 'interventionNames': ['Device: Control']}], 'interventions': [{'name': 'taVNS 10', 'type': 'DEVICE', 'description': 'Patients were given taVNS (by Xi\'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs)', 'armGroupLabels': ['Treatment group 1']}, {'name': 'taVNS 25', 'type': 'DEVICE', 'description': 'Patients were given taVNS (by Xi\'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 25 Hz; current intensity: minimal pain threshold; pulse width: 500 μs)', 'armGroupLabels': ['Treatment group 2']}, {'name': 'Control', 'type': 'DEVICE', 'description': 'Patients were given taVNS (by Xi\'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lanzhou', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojun Huang, M.D.', 'role': 'CONTACT'}], 'facility': 'Lanzhou University Second Hospital', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanglin Pan, M.D.', 'role': 'CONTACT', 'email': 'yanglinpan@hotmail.com', 'phone': '13991811225', 'phoneExt': '86-29-84771536'}], 'facility': 'Xijing Hospital of Digestive Diseases', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Na Liu, M.D.', 'role': 'CONTACT'}], 'facility': "The Second Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Yanglin Pan, M.D.', 'role': 'CONTACT', 'email': 'yanglinpan@hotmail.com', 'phone': '13991811225'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Other researchers can contact PI to get IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'Yanglin Pan', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}