Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-02 @ 1:16 AM
Study NCT ID:
NCT04677751
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2020-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Electrographic Changes in Responsive Neurostimulation System (RNS) Patients with Acupuncture Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in number of disabling clinical seizures', 'timeFrame': 'Baseline,12 weeks post treatment', 'description': 'This will be measured by self reporting journals'}, {'measure': 'Changes in seizure severity', 'timeFrame': 'Baseline,12 weeks post treatment', 'description': 'This will be measured by self reporting journals'}], 'secondaryOutcomes': [{'measure': 'Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire', 'timeFrame': 'Baseline,12 weeks post treatment', 'description': 'This is a 10 item questionnaire. Score ranges from 1-6,a higher number indicating a worse outcome.'}, {'measure': 'Change in cognition and mood as assessed by the Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Baseline,12 weeks post treatment', 'description': 'PHQ-9 score can range from 0 to 27,each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).'}, {'measure': 'Change in cognition and mood as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale', 'timeFrame': 'Baseline,12 weeks post treatment', 'description': 'This is a 7 item questionnaire. Each question is scored form 0(not at alll) to 3(nearly every day)'}, {'measure': 'Average number of detections of seizures per-day (as stored by the RNS System)', 'timeFrame': 'Baseline'}, {'measure': 'Average number of detections of seizures per-day (as stored by the RNS System)', 'timeFrame': 'end of 1 month'}, {'measure': 'Average number of detections of seizures per-day (as stored by the RNS System)', 'timeFrame': 'end of 2 months'}, {'measure': 'Average number of detections of seizures per-day (as stored by the RNS System)', 'timeFrame': 'end of 3 months'}, {'measure': 'Average number of detections of seizures per-day (as stored by the RNS System)', 'timeFrame': '1 month after last treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['acupuncture', 'RNS', 'seizure'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine effects of Acupuncture on a Patient's mood and cognition,evaluate changes in clinically-reported seizure frequency and severity and analyze effects of Acupuncture on electrographic epileptiform activity stored by the RNS System"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient implanted with the RNS system\n* Patient can undergo 12 weeks of acupuncture\n* Patient is able remain on stable medications for 12 weeks\n* Patient is able to remain on stable Detection and Stimulation settings for 12 weeks\n* Patient or/and caregiver is able to understand and sign informed consent and HIPAA authorization\n* Patient or caregiver able to maintain a seizure diary for duration of study\n\nExclusion Criteria:\n\n* Patient and /or caregiver is unable to sign informed consent to study\n* Patient has a bleeding disorder, pacemaker, or pregnant'}, 'identificationModule': {'nctId': 'NCT04677751', 'briefTitle': 'Clinical and Electrographic Changes in Responsive Neurostimulation System (RNS) Patients with Acupuncture Treatment', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Clinical and Electrographic Changes in RNS System Patients with Acupuncture Treatment', 'orgStudyIdInfo': {'id': 'HSC-MS-20-0743'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'interventionNames': ['Device: Acupuncture intervention']}], 'interventions': [{'name': 'Acupuncture intervention', 'type': 'DEVICE', 'description': 'Participants will undergo 12 weeks of acupuncture therapy. There will be one 40 minute-1 hour. session per week.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Olga Rodziyevska, MS,PA-C', 'role': 'CONTACT', 'email': 'Olga.Rodziyevska@uth.tmc.edu', 'phone': '(713) 500-5482'}, {'name': 'Ardonia N Tousant', 'role': 'CONTACT', 'email': 'Ardonia.N.Tousant@uth.tmc.edu', 'phone': '(713) 500-5482'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Olga Rodziyevska, MS,PA-C', 'role': 'CONTACT', 'email': 'Olga.Rodziyevska@uth.tmc.edu', 'phone': '(713) 500-5482'}, {'name': 'Ardonia N Tousant', 'role': 'CONTACT', 'email': 'Ardonia.N.Tousant@uth.tmc.edu', 'phone': '(713) 500-5482'}], 'overallOfficials': [{'name': 'Olga Rodziyevska, MS,PA-C', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician Assistant', 'investigatorFullName': 'Olga Rodziyevska', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}