Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-03-06 @ 10:21 PM
Study NCT ID:
NCT07084792
Status:
WITHDRAWN
Last Update Posted:
2025-08-22
First Post:
2025-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Motor Cortical Responses to Subdural Electrical Stimulation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study team is no longer moving forward with this study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of arm movements in 60 seconds', 'timeFrame': '60 seconds', 'description': 'Number of arm movements in 60 seconds'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinsons'], 'conditions': ['Parkinsons Disease (PD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to better understand how subdural electrical stimulation of the brain affects motor cortical oscillations', 'detailedDescription': "Direct cortical stimulation (DCS) has shown the potential to improve symptoms in patients with Parkinson's disease, however its effects have not been consistent in randomized studies to date, limiting widespread adoption of this technology. A critical gap in our knowledge is a detailed understanding of how DCS affects motor areas in the brain. Investigators propose using subdural DCS (sDCS) while simultaneously recording directly from motor cortex using subdural electrocorticography (sECoG) in patients undergoing deep brain stimulation surgery. Investigators expect this novel approach to broaden our understanding of sDCS application and possibly lead to therapeutic advances in this population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with PD and consented and scheduled for DBS surgery with the PI\n* Age 18-80\n\nExclusion Criteria:\n\n* Patients unable to actively participate in the consent process physically and/or cognitively\n* Previous adverse reaction to Keppra (levetiracetam)\n* Prior intracranial surgery with the exception of deep brain stimulation surgery\n* Prior brain radiotherapy\n* Prior history of intracranial tumor, intracranial infection or cerebrovascular malformation\n* Prior history of seizures'}, 'identificationModule': {'nctId': 'NCT07084792', 'briefTitle': 'Dynamic Motor Cortical Responses to Subdural Electrical Stimulation.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Dynamic Motor Cortical Responses to Subdural Electrical Stimulation.', 'orgStudyIdInfo': {'id': 'Pro00142103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects will undergo stimulation with the device', 'interventionNames': ['Device: Direct cortical stimulation']}], 'interventions': [{'name': 'Direct cortical stimulation', 'type': 'DEVICE', 'description': 'Stimulation', 'armGroupLabels': ['Subjects will undergo stimulation with the device']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nathan Rowland, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}