Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-02 @ 12:23 AM
Study NCT ID:
NCT02378792
Status:
UNKNOWN
Last Update Posted:
2016-10-12
First Post:
2015-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055536', 'term': 'Vagus Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-11', 'studyFirstSubmitDate': '2015-02-27', 'studyFirstSubmitQcDate': '2015-03-03', 'lastUpdatePostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month', 'timeFrame': '4,8,12,16,20,24 months of stimulation'}], 'secondaryOutcomes': [{'measure': 'Changes in seizure frequency from baseline to the seizure count evaluvation period', 'timeFrame': '4,8,12,16,20,24 months of stimulation', 'description': 'Changes in seizure frequency from baseline to 4,8,12,16,20,24 months'}, {'measure': 'Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment', 'timeFrame': 'Mean change from baseline QOLIE-31 Overall Score at 12,24 months', 'description': 'QOLIE-31 contains 7 multi-item scales that tap the following health concepts:overall quality of life, emotional well-being, social functioning, energy/fatigue, worry about seizure,cognitive functioning,medication effects. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.'}, {'measure': 'Changes in the Number of Anti-epileptic Drugs Prescribed', 'timeFrame': 'At12,24 months', 'description': 'Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures'}, {'measure': 'Changes from Basline in the Engel and McHugh description', 'timeFrame': 'At 12,24 months'}, {'measure': 'Changes from Basline in 24 hour ECG description', 'timeFrame': 'At 12,24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PINS VNS Refractory Epilepsy'], 'conditions': ['Refractory Epilepsy']}, 'referencesModule': {'references': [{'pmid': '32471438', 'type': 'DERIVED', 'citation': 'Liu H, Zhan P, Meng F, Wang W. Chronic vagus nerve stimulation for drug-resistant epilepsy may influence fasting blood glucose concentration. Biomed Eng Online. 2020 May 29;19(1):40. doi: 10.1186/s12938-020-00784-1.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory epilepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 6-60.\n2. Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.\n3. At least 1 seizure per month.\n4. In good health except epilepsy.\n5. With normal MMSE score\n6. Patients or his(her) familyscould understand this method and sign the informed consent 7）Patients with good compliance and could complete postoperative follow-up.\n\nExclusion Criteria:\n\n1. Results of MRI remind epilepsy caused by intracranial space-occupying lesions.\n2. The vagus nerve lesion and damage\n3. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes Type 1，bad health etc, and other surgical contraindication\n4. Alcohol addiction, smoking, and sleep-related breathing disorders'}, 'identificationModule': {'nctId': 'NCT02378792', 'acronym': 'VNSRE', 'briefTitle': 'Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Pins Medical Co., Ltd'}, 'officialTitle': 'The Clinical Research on TsingHua Vagus Nerve Stimualtor for Treatment of Refractory Epilepsy', 'orgStudyIdInfo': {'id': 'PINS-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vagus Verve Stimulation is on', 'interventionNames': ['Device: Vagus Nerve Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo Vagus Verve Stimulation is off', 'interventionNames': ['Device: Vagus Nerve Stimulation']}], 'interventions': [{'name': 'Vagus Nerve Stimulation', 'type': 'DEVICE', 'otherNames': ['PINS Stimulator System'], 'description': 'Vagus Nerve Stimulator', 'armGroupLabels': ['Placebo Vagus Verve Stimulation is off', 'Vagus Verve Stimulation is on']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianguo Zhang, MD', 'role': 'CONTACT', 'email': 'Limuxin2011@163.com', 'phone': '010-67096611'}], 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kan Xu, MD', 'role': 'CONTACT'}, {'name': 'Jiqing Qiu', 'role': 'CONTACT'}], 'facility': 'The first hospital of jilin university', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '110011', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guobiao Liang, MD', 'role': 'CONTACT'}, {'name': 'Guanqian Yuan', 'role': 'CONTACT'}], 'facility': 'The general of shenyang military', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shujun Xu, MD', 'role': 'CONTACT'}, {'name': 'Wenhua Zhang', 'role': 'CONTACT'}], 'facility': 'Qilu hospital of shandong university', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiming FU, MD', 'role': 'CONTACT'}, {'name': 'Junming Zhu', 'role': 'CONTACT'}], 'facility': 'The second affiliated hospital zhejiang university school of medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Jia Fumin, PhD', 'role': 'CONTACT', 'email': 'pins_medical@163.com', 'phone': '+86 010-59361265'}, {'name': 'Li Luming, PhD', 'role': 'CONTACT', 'phone': '+86 010-60736388'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Pins Medical Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}