Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-02 @ 9:23 AM
Study NCT ID:
NCT04164056
Status:
UNKNOWN
Last Update Posted:
2019-11-15
First Post:
2019-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hippocampal and Thalamic DBS for Bilateral Temporal Lobe Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004833', 'term': 'Epilepsy, Temporal Lobe'}], 'ancestors': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-13', 'studyFirstSubmitDate': '2019-10-10', 'studyFirstSubmitQcDate': '2019-11-13', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events Rate', 'timeFrame': '1 year and 3 years after DBS', 'description': 'The rate of adverse events related to the implantation surgery or DBS devices.'}], 'primaryOutcomes': [{'measure': 'Responder Rate', 'timeFrame': '3 years after DBS', 'description': 'The rate of patients response to DBS, patients have at least 50% decrease in average seizure frequency after DBS are considered as responder.'}, {'measure': 'Seizure-Free Rate', 'timeFrame': '3 years after DBS', 'description': "The rate of patients who achieve seizure free after DBS. Patients don't have seizure for at least 1 year are considered seizure free."}, {'measure': 'Change in Seizure Frequency', 'timeFrame': '3 years after DBS', 'description': 'The seizure frequency after DBS compared to the seizure frequency in baseline.'}], 'secondaryOutcomes': [{'measure': 'Change in Percentage of Seizure-free Days', 'timeFrame': '1 year and 3 years after DBS', 'description': 'The percentage of seizure-free days after DBS compared to the percentage of seizure-free days in baseline.'}, {'measure': 'Change in the Maximum Length of Seizure Intervals', 'timeFrame': '1 year and 3 years after DBS', 'description': 'The maximum length of seizure intervals after DBS compared to the maximum length of seizure intervals in baseline.'}, {'measure': 'Change in GTCS Frequency', 'timeFrame': '1 year and 3 years after DBS', 'description': 'The GTCS frequency after DBS compared to the GTCS frequency in baseline.'}, {'measure': 'Incidence Rate of Sudden Unexplained Death in Epilepsy (SUDEP)', 'timeFrame': '1 year and 3 years after DBS', 'description': 'The Incidence Rate after DBS.'}, {'measure': 'Change in Memory', 'timeFrame': '1 year and 3 years after DBS', 'description': 'The memory test scores after DBS compared to baseline. Wechsler memory scale (WMS, ≤51 \\~ 150, higher scores mean better outcome)'}, {'measure': 'Change in Cognitive Function', 'timeFrame': '1 year and 3 years after DBS', 'description': 'The cognitive test scores after DBS compared to baseline. Montreal Cognitive Assessment(MoCA, 0-30 scores, higher scores mean better outcome)'}, {'measure': 'Change in Depression', 'timeFrame': '1 year and 3 years after DBS', 'description': 'The depression test scores after DBS compared to baseline. Hamilton depression scale (HAMD, 0-64 scores, lower scores mean better outcome)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy, Temporal Lobe']}, 'referencesModule': {'references': [{'pmid': '20331461', 'type': 'RESULT', 'citation': 'Fisher R, Salanova V, Witt T, Worth R, Henry T, Gross R, Oommen K, Osorio I, Nazzaro J, Labar D, Kaplitt M, Sperling M, Sandok E, Neal J, Handforth A, Stern J, DeSalles A, Chung S, Shetter A, Bergen D, Bakay R, Henderson J, French J, Baltuch G, Rosenfeld W, Youkilis A, Marks W, Garcia P, Barbaro N, Fountain N, Bazil C, Goodman R, McKhann G, Babu Krishnamurthy K, Papavassiliou S, Epstein C, Pollard J, Tonder L, Grebin J, Coffey R, Graves N; SANTE Study Group. Electrical stimulation of the anterior nucleus of thalamus for treatment of refractory epilepsy. Epilepsia. 2010 May;51(5):899-908. doi: 10.1111/j.1528-1167.2010.02536.x. Epub 2010 Mar 17.'}, {'pmid': '25663221', 'type': 'RESULT', 'citation': 'Salanova V, Witt T, Worth R, Henry TR, Gross RE, Nazzaro JM, Labar D, Sperling MR, Sharan A, Sandok E, Handforth A, Stern JM, Chung S, Henderson JM, French J, Baltuch G, Rosenfeld WE, Garcia P, Barbaro NM, Fountain NB, Elias WJ, Goodman RR, Pollard JR, Troster AI, Irwin CP, Lambrecht K, Graves N, Fisher R; SANTE Study Group. Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy. Neurology. 2015 Mar 10;84(10):1017-25. doi: 10.1212/WNL.0000000000001334. Epub 2015 Feb 6.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to compare the safety and effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for reducing the frequency of seizures in patients with bilateral temporal lobe epilepsy.', 'detailedDescription': 'The outcome of resective surgery for bilateral temporal lobe epilepsy (BTLE) is poor. Neuromodulation such as deep brain stimulation is an alternative therapy for patients with drug-resistant epilepsy, especially for those not suitable for resective surgery. This prospective, randomized, open-label trial aims to compare the effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for bilateral temporal lobe epilepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients between 12 to 60 years old.\n2. Bilateral temporal lobe epilepsy patients proved by VEEG or SEEG.\n3. At least 3 seizures per month but not more than 10 seizures per month, and the longest seizure interval is no more than 30 days during the baseline.\n4. Patients failed to at least 3 antiepileptic drugs (AEDs), and are receiving at least 1 AEDs now.\n5. Be able to complete seizure diary.\n6. Agree to participate this study and sign informed consent.\n\nExclusion Criteria:\n\n1. Extratemporal lobe epilepsy or with potential extratemporal epileptogenic focus.\n2. Patients with psychogenic non-epileptic seizures.\n3. IQ \\< 70, or unable to complete the study.\n4. Patients are pregnant or plan for it.\n5. Patients with implanted electrical stimulation medical device.\n6. Patients with other severe neuropsychiatric disorders such as dementia, schizophrenia, or neurodegenerative diseases.\n7. Patients with cerebral lesions which unsuitable for lead implantation.'}, 'identificationModule': {'nctId': 'NCT04164056', 'briefTitle': 'Hippocampal and Thalamic DBS for Bilateral Temporal Lobe Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Hippocampal and Thalamic Deep Brain Stimulation for Bilateral Temporal Lobe Epilepsy', 'orgStudyIdInfo': {'id': '2019-192'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stimulation on the hippocampus', 'description': 'deep brain stimulation on the hippocampus', 'interventionNames': ['Device: deep brain stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'stimulation on the anterior nucleus of the thalamus', 'description': 'deep brain stimulation on the anterior nucleus of the thalamus', 'interventionNames': ['Device: deep brain stimulation']}], 'interventions': [{'name': 'deep brain stimulation', 'type': 'DEVICE', 'description': 'deep brain stimulation on the hippocampus or the anterior nucleus of the thalamus', 'armGroupLabels': ['stimulation on the anterior nucleus of the thalamus', 'stimulation on the hippocampus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuang Wang, MD', 'role': 'CONTACT', 'email': 'wangs77@zju.edu.cn', 'phone': '+86 0571-87767120'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Shuang Wang, MD', 'role': 'CONTACT', 'email': 'wangs77@zju.edu.cn', 'phone': '+86 0571-87767120'}], 'overallOfficials': [{'name': 'Shuang Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Epilepsy Center, Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, {'name': 'The Second Hospital of Hebei Medical University', 'class': 'OTHER'}, {'name': "Zhejiang Provincial People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}