Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2026-01-01 @ 10:16 PM
Study NCT ID:
NCT07014592
Status:
RECRUITING
Last Update Posted:
2025-06-11
First Post:
2025-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization and Analysis of Evoked Cortical Responses in Participants With Medication-intractable 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': 'D004566', 'term': 'Electrodes'}], 'ancestors': [{'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2025-05-24', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of time-frequency data', 'timeFrame': 'During a 20 minute research phase of a clinically indicated surgery', 'description': 'From recording electrodes'}, {'measure': 'Characterization of local field responses (LFPs)', 'timeFrame': 'During a 20 minute research phase of a clinically indicated surgery', 'description': 'From recording electrodes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Intractable Epilepsy']}, 'descriptionModule': {'briefSummary': 'The goal of this project is to study how the brain reacts to a small electrical signal. Researchers will be using a novel combination of recording electrodes. The researchers will measure the brain response from these electrodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with medication intractable epilepsy who are recommended to undergo brain surgery to remove a "seizure" focus\n* Can provide informed consent for the study and willing to participate\n\nExclusion Criteria:\n\n* Presence of a permanent electronic implant\n* Any chronic medical conditions that prevent safe placement of electrodes'}, 'identificationModule': {'nctId': 'NCT07014592', 'briefTitle': 'Characterization and Analysis of Evoked Cortical Responses in Participants With Medication-intractable Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Characterization and Analysis of Evoked Cortical Responses in Participants With Medication-intractable Epilepsy', 'orgStudyIdInfo': {'id': 'HUM00258281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medication-intractable epilepsy', 'interventionNames': ['Device: stimulating probes and electrodes']}], 'interventions': [{'name': 'stimulating probes and electrodes', 'type': 'DEVICE', 'description': 'Subdural electrodes and/or ball tip probes will be used intraoperatively to provide electrical stimulation to the brain.', 'armGroupLabels': ['Medication-intractable epilepsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ron Ball', 'role': 'CONTACT', 'email': 'rmball@umich.edu', 'phone': '734-936-7010'}, {'name': 'Matthew Willsey, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Ron Ball', 'role': 'CONTACT', 'email': 'rmball@umich.edu', 'phone': '734 936-7010'}], 'overallOfficials': [{'name': 'Matthew Willsey, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The aspects of a plan for sharing are still under determination.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Neurosurgery', 'investigatorFullName': 'Matthew S Willsey', 'investigatorAffiliation': 'University of Michigan'}}}}