Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-26 @ 6:52 AM
Study NCT ID:
NCT05075850
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2021-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PatiEnt Neuropsychological outcomeS After laseR Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cseligman@monteris.com', 'phone': '(952) 463-7747', 'title': 'Christa Seligman', 'organization': 'Monteris Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline testing can occur any time prior to LITT. Follow-up testing occurs at least 6 months after LITT', 'description': 'No adverse events are collected for the PENSAR study.', 'eventGroups': [{'id': 'EG000', 'title': 'PENSAR Subjects', 'description': 'All eligible study subjects who underwent LITT with the NeuroBlate System and completed study-related testing.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 0, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Site-determined Cognitive Changes Per Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PENSAR Subjects Baseline', 'description': 'All eligible study subjects who underwent LITT with the NeuroBlate System and completed Baseline study related testing'}, {'id': 'OG001', 'title': 'PENSAR Subjects Follow-Up', 'description': 'All eligible study subjects who underwent LITT with the NeuroBlate System and completed Follow-Up study related testing'}], 'classes': [{'title': 'Boston Naming (range 13-60. Higher score is better)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '50.7', 'spread': '6.6', 'groupId': 'OG001'}]}]}, {'title': 'Trails Making (range 16-291. Higher value is worse)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.9', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '35.3', 'spread': '27.7', 'groupId': 'OG001'}]}]}, {'title': 'Wechsler Adult Intelligence Scale 3 Digital Span (range 2-58. Lower score is better)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'Logical Memory (range 0-32. Higher score is better)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.3', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Brief Visuospacial Memory Test (range 0-33. Higher score is better)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.1', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Animal Fluency (range 7-30. Higher score is better)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.9', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'Grooved Pegboard (Range 49-243. Lower score is better)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.0', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '77.2', 'spread': '19.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': "At least six months from baseline assessment. Subjects were analyzed even if they only had 1 test performed. The baseline test information can still be used even if they didn't have follow up testing done.", 'description': 'Neuropsychological test data collected will describe cognitive domain specific changes as a cohort. Change will be assessed from raw test scores and demographically corrected standardized scores (where available). For this study, collected cognitive domains include Language (Boston Naming Test), Executive Function (Trails Making Test), Attention (Wechsler Adult Intelligence Scale 3 Digital Span Test), Verbal Memory (Logical Memory Test), Visual Memory (Brief Visiospacial Memory Test), Verbal Fluency (Animal Fluency Test), and Motor Function (Grooved Pegboard Test).', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who had LITT and completed baseline and follow-up testing.'}, {'type': 'SECONDARY', 'title': 'Change in Raw Test Scores From Standard Battery of Preferred Neuropsychological Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PENSAR Subjects', 'description': 'All eligible study subjects who underwent LITT with the NeuroBlate System and completed study-related testing.'}], 'classes': [{'title': 'Number of subjects who saw no change or improvement in Boston Naming Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Number of subjects who saw no change or improvement in Trails Making Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Number of subjects with no change or improvement in Wechsler Adult Intelligence 3 Digital Span Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Number of subjects who saw no change or improvement in Logical Memory Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Number of subjects who saw no change or improvement in Brief Visiospatial Memory Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Number of subjects who saw no change or improvement in Animal Fluency Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Number of subjects who saw no change or improvement in Grooved Pegboard Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': "At least six months from baseline assessment.Subjects were analyzed even if they only had 1 test performed. The baseline test information can still be used even if they didn't have follow up testing done.", 'description': 'Describe the observed change or stability of neuropsychological test scores in patients who underwent laser ablation surgery. Change will be assessed from raw test scores and demographically corrected standardized scores (where available). For this study, tests include Boston Naming, Trails making Test A and Test B, Digit Span, Logical memory test (subtest from Wechsler Memory Scale IV), BVMT--Brief Visuospatial Memory Test, Animal Fluency test, and Grooved Pegboard.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who had LITT and completed baseline and follow-up testing'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PENSAR Subjects', 'description': 'All eligible study subjects who underwent LITT with the NeuroBlate System and completed study-related testing.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Did not completed follow-up questionnaires', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PENSAR Subjects', 'description': 'All eligible study subjects who underwent LITT with the NeuroBlate System and completed study-related testing.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '38.1', 'spread': '13.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', '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': '42', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '47 subjects completed baseline PENSAR study testing.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-21', 'size': 451570, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-04T11:32', 'hasProtocol': True}, {'date': '2021-08-21', 'size': 113433, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-04T11:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2021-09-15', 'resultsFirstSubmitDate': '2024-09-27', 'studyFirstSubmitQcDate': '2021-10-08', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-04', 'studyFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Site-determined Cognitive Changes Per Domain', 'timeFrame': "At least six months from baseline assessment. Subjects were analyzed even if they only had 1 test performed. The baseline test information can still be used even if they didn't have follow up testing done.", 'description': 'Neuropsychological test data collected will describe cognitive domain specific changes as a cohort. Change will be assessed from raw test scores and demographically corrected standardized scores (where available). For this study, collected cognitive domains include Language (Boston Naming Test), Executive Function (Trails Making Test), Attention (Wechsler Adult Intelligence Scale 3 Digital Span Test), Verbal Memory (Logical Memory Test), Visual Memory (Brief Visiospacial Memory Test), Verbal Fluency (Animal Fluency Test), and Motor Function (Grooved Pegboard Test).'}], 'secondaryOutcomes': [{'measure': 'Change in Raw Test Scores From Standard Battery of Preferred Neuropsychological Tests', 'timeFrame': "At least six months from baseline assessment.Subjects were analyzed even if they only had 1 test performed. The baseline test information can still be used even if they didn't have follow up testing done.", 'description': 'Describe the observed change or stability of neuropsychological test scores in patients who underwent laser ablation surgery. Change will be assessed from raw test scores and demographically corrected standardized scores (where available). For this study, tests include Boston Naming, Trails making Test A and Test B, Digit Span, Logical memory test (subtest from Wechsler Memory Scale IV), BVMT--Brief Visuospatial Memory Test, Animal Fluency test, and Grooved Pegboard.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Quality of Life', 'Neuropsychological Test Scores', 'Visual Field'], 'conditions': ['Cognitive Change']}, 'descriptionModule': {'briefSummary': 'PatiEnt Neuropsychological outcomeS After laseR ablation', 'detailedDescription': 'This is a multicenter sub-study that will include comprehensive neuropsychological assessment data collection done at baseline (within 1 year prior to the index LITT procedure) and at follow-up (at least 6 months from the index LITT procedure). Visual field testing will be conducted in a subset of enrolled patients. Up to 250 subjects may be enrolled at up to 15 study sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study is being conducted as a sub-study within the LAANTERN registry; therefore, all enrolled patients in PENSAR must be consented to both protocols.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient or legally authorized representative provides written authorization and/or consent.\n2. Patient is enrolled in the LAANTERN trial and had an epilepsy diagnosis without the presence of a malignant brain tumor.\n3. Patient is 16 years of age or older.\n4. Patient has completed a baseline comprehensive neuropsychological assessment with a neuropsychologist.\n\nExclusion Criteria:\n\n1\\. Patient does not complete the index LITT procedure as specified in the LAANTERN registry.'}, 'identificationModule': {'nctId': 'NCT05075850', 'acronym': 'PENSAR', 'briefTitle': 'PatiEnt Neuropsychological outcomeS After laseR Ablation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Monteris Medical'}, 'officialTitle': 'PatiEnt Neuropsychological outcomeS After laseR Ablation', 'orgStudyIdInfo': {'id': 'PENSAR LAANTERN Registry'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Neuroblate System', 'type': 'DEVICE', 'description': 'All subjects will undergo comprehensive neuropsychological assessment post-LITT per standard of care practice.\n\nVisual field testing will be conducted in a subset of enrolled patients.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Health Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40241', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Healthcare', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Patrick Landazuri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monteris Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}