Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-02 @ 5:00 AM
Study NCT ID:
NCT04710004
Status:
TERMINATED
Last Update Posted:
2024-03-05
First Post:
2021-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Electrophysiological Biomarkers in MTLE Patients.
Sponsor:
Organization:
Raw JSON
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Spectral power is measured in microvolts. A change in either direction from baseline is associated with a better outcome.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected. Subject was discharged before testing could be completed.'}, {'type': 'PRIMARY', 'title': 'Change in Intracranial EEG Recording: Synchrony From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brain Stimulation Via Clinically Implanted Electrodes', 'description': 'Brain will be stimulated in different patterns including synchronized or asynchronous current.\n\nAsynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device: Participants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies.'}], 'timeFrame': 'Baseline, up to 6 weeks postintervention', 'description': 'Synchrony will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates synchrony during the preictal, ictal or post ictal states. Synchrony is a measure of how any pair of regions communicate with one another. Synchrony is measured as the correlation \\[-1 to 1\\] between two time series.\n\nThe investigators anticipate that a decrease in synchrony (correlation approaching 0) is associated with improved outcome.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected. Subject was discharged before testing could be completed.'}, {'type': 'SECONDARY', 'title': 'Changes in Memory During Brain Stimulation From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brain Stimulation Via Clinically Implanted Electrodes', 'description': 'Brain will be stimulated in different patterns including synchronized or asynchronous current.\n\nAsynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device: Participants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies.'}], 'timeFrame': 'Baseline, up to 6 weeks postintervention', 'description': 'Patients will be asked to recall a list of words after a 20-second delay in which they will do simple math problems to ensure long-term memory encoding. Three \\~1-2-hour sessions will be performed; each session will consist of 24 free recall tasks (12 during ADMES and 12 with no stimulation). The memory score will be assessed as the percentage correct out of 12. The higher the percentage recalled, the better the score.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected. Subject was discharged before testing could be completed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brain Stimulation Via Clinically Implanted Electrodes', 'description': 'Brain will be stimulated in different patterns including synchronized or asynchronous current.\n\nAsynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device: Participants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Brain Stimulation Via Clinically Implanted Electrodes', 'description': 'Brain will be stimulated in different patterns including synchronized or asynchronous current.\n\nAsynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device: Participants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-09', 'size': 723973, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-12T11:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Lack of funding to secure effort for testing.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2021-01-13', 'resultsFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-04', 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Intracranial EEG Recording: Spectral Power From Baseline', 'timeFrame': 'Baseline, up to 6 weeks postintervention', 'description': 'Spectral power will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates spectral power during the preictal, ictal or post ictal states. Spectral power is measured in microvolts. A change in either direction from baseline is associated with a better outcome.'}, {'measure': 'Change in Intracranial EEG Recording: Synchrony From Baseline', 'timeFrame': 'Baseline, up to 6 weeks postintervention', 'description': 'Synchrony will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates synchrony during the preictal, ictal or post ictal states. Synchrony is a measure of how any pair of regions communicate with one another. Synchrony is measured as the correlation \\[-1 to 1\\] between two time series.\n\nThe investigators anticipate that a decrease in synchrony (correlation approaching 0) is associated with improved outcome.'}], 'secondaryOutcomes': [{'measure': 'Changes in Memory During Brain Stimulation From Baseline', 'timeFrame': 'Baseline, up to 6 weeks postintervention', 'description': 'Patients will be asked to recall a list of words after a 20-second delay in which they will do simple math problems to ensure long-term memory encoding. Three \\~1-2-hour sessions will be performed; each session will consist of 24 free recall tasks (12 during ADMES and 12 with no stimulation). The memory score will be assessed as the percentage correct out of 12. The higher the percentage recalled, the better the score.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Epilepsy', 'Biomarkers'], 'conditions': ['Mesial Temporal Lobe Epilepsy']}, 'descriptionModule': {'briefSummary': 'The investigators plan to enroll individuals with medical temporal lobe epilepsy who are undergoing surgical workup with clinically implanted intracranial electrodes. The study intends to administer computerized memory tasks and stimulation during the intracranial Electroencephalography (EEG) monitoring period.', 'detailedDescription': 'This is a nonrandomized interventional trial that will apply brain stimulation via clinically implanted intracranial electrodes to subjects with medial temporal lobe epilepsy with the purpose of identifying biomarkers related to the pre-ictal state; to perform an acute parameter search to determine the stimulation pattern that most effectively modifies these biomarkers and to identify changes in memory (free recall) during asynchronous distributed multi-electrode stimulation (ADMES).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Male or female, aged 18-65\n3. Diagnosed with lesional or non-lesional mesial temporal (hippocampal) seizure onset confirmed on SEEG monitoring\n4. Implanted with depth electrodes for localization of seizure onset with multiple hippocampal electrode arrays\n\nExclusion criteria:\n\n1. Any patient who is unwilling or unable to provide consent\n2. Women who are pregnant\n3. Patients under 18 years\n4. Incarcerated persons'}, 'identificationModule': {'nctId': 'NCT04710004', 'briefTitle': 'Electrophysiological Biomarkers in MTLE Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Electrophysiological Biomarkers During Invasive Monitoring of Mesial Temporal Lobe Epilepsy Patients.', 'orgStudyIdInfo': {'id': 'STUDY00001554'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brain stimulation via clinically implanted electrodes', 'description': 'Brain will be stimulated in different patterns including synchronized or asynchronous current.', 'interventionNames': ['Device: Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device']}], 'interventions': [{'name': 'Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device', 'type': 'DEVICE', 'otherNames': ['ADMES'], 'description': 'Participants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies.', 'armGroupLabels': ['Brain stimulation via clinically implanted electrodes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Epilepsy monitoring unit (EMU) at Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Robert Gross, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert Gross', 'investigatorAffiliation': 'Emory University'}}}}