Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-22 @ 10:52 AM
Study NCT ID:
NCT03630302
Status:
COMPLETED
Last Update Posted:
2021-05-28
First Post:
2018-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'erika.ross@abbott.com', 'phone': '972-526-8207', 'title': 'Erika Ross', 'organization': 'Abbott neuromodulation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Medications/anesthesia could have an important effect on the LFP signal characteristic. For this reason local anesthesia should be used, as administration of anesthesia like propofol can wipe out or change the frequency spectrum of LFPs dramatically.'}}, 'adverseEventsModule': {'timeFrame': 'surgery to 3 month post-surgery visit', 'description': 'Both motor and non-motor side effect-induced adverse events were examined and reported.', 'eventGroups': [{'id': 'EG000', 'title': 'LFP Recording Patients', 'description': 'All patients underwent STN DBS implants, 9/10 patients obtained LFP recordings during surgery. The 9 patients were then revisited for 3 month post-op followup.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'increased falls', 'notes': 'patient experienced increased gait issues and falls during Med off / stim on scenarios, the patient was withdrawn due to inability to tolerate off medication study assessments', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}, {'term': 'cognitive impairment', 'notes': 'patient became confused intraoperatively but surgical procedure was completed as planned. Due to persistent altered mental state, and MRI was ordered and showed bilateral edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}, {'units': 'DBS leads', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LFP Analyses From Patients With Bilateral Implants', 'description': 'all DBS leads from all patients that LFP analyses were performed on and clinical programming were obtained'}], 'classes': [{'title': 'DBS leads that had clinical programming contact that matched highest beta-band power', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'DBS leads that had clinical programming row that matched highest beta-band power', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'DBS leads that had clinical programming electrode that matched highest HFO power', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'DBS leads that had clinical programming row that matched highest HFO power', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'DBS leads that had clinical programming electrode that matched highest CFC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'DBS leads that had clinical programming row that matched highest CFC', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'LFPs were analyzed after DBS implant procedure, clinical programming were done at 3 month followup', 'description': 'From all DBS leads (2 per patient):\n\nLocal field potentials (LFPs) were measured intraoperatively during DBS implant. Features such as beta band power (10-30Hz), high-frequency oscillation power (200-400Hz, HFO), as well as the cross frequency coupling between beta band power and HFO (CFC) were extracted from the LFP recordings from all electrodes. Electrodes with the most beta band power, most HFOs, and most CFC were documented.\n\nAt 3 month post-op visit, the clinically programmed stimulation electrodes were documented, and were compared to the electrodes documented from the intraoperative LFP measures. Both matches in the exact contact and the row at which the contacts were in were documented and compared.', 'unitOfMeasure': 'DBS leads', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'DBS leads', 'denomUnitsSelected': 'DBS leads', 'populationDescription': 'patients who had both LFP data and clinical programming results, all patients have bilateral implants'}, {'type': 'SECONDARY', 'title': 'Number of DBS Leads With the Highest Side Effect Threshold at 3 Months That Were Consistent With Predictions Derived From LFPs After DBS Implant Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}, {'units': 'DBS leads', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LFP Analyses From Patients With Bilateral Implants', 'description': 'all DBS leads from all patients that LFP analyses were performed on and clinical programming were obtained'}], 'classes': [{'title': 'DBS leads that had highest side effect threshold contact predicted by HFO', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'DBS leads that had highest side effect threshold contact predicted by CFC', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'DBS leads that had highest side effect threshold contact predicted by beta-band power', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'LFPs were measured during DBS implant procedure, clinical programming were done at 3 month followup evaluation', 'description': 'From all DBS leads (2 per patient):\n\nLocal field potentials (LFPs) were measured intraoperatively during DBS implant. Features such as beta band power (10-30Hz), high-frequency oscillation power (200-400Hz, HFO), as well as the cross frequency coupling between beta band power and HFO (CFC) were extracted from the LFP recordings from all electrodes. Electrodes with the most beta band power, most HFOs, and most CFC were documented.\n\nAt 3 month post-op visit, the stimulation electrode that produced the largest side effect threshold (any side effect) were documented, and were compared to the electrodes with the largest beta band, HFO, and CFC power documented from the intraoperative LFP measures.', 'unitOfMeasure': 'DBS leads', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'DBS leads', 'denomUnitsSelected': 'DBS leads', 'populationDescription': 'all patients with LFP data and who have gone through 3 month evaluation of side effect thresholds, each with bilateral implants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LFP Recording Patients', 'description': 'All patients underwent STN DBS implants. The DBS leads were programmed by clinicians at initial visit and symptoms re-evaluated at 3 month post-operative visit. Local field potentials (LFPs) were recorded from 9 patients during the surgery of DBS implants. Hardware issue prevented LFP recordings from 1 patient.'}], 'periods': [{'title': 'Surgery', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'hardware issue prevented LFP recordings', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': '3 Month Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}, {'title': 'Data Post Analyses', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'IRB issues prevented data from being analyzed and transferred', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Patients', 'description': 'All patients underwent STN DBS implants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59.3', 'spread': '5.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'How long has the patient been diagnosed with PD', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8.95', 'spread': '4.11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-29', 'size': 1170062, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-15T10:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2018-08-09', 'resultsFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-06', 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure', 'timeFrame': 'LFPs were analyzed after DBS implant procedure, clinical programming were done at 3 month followup', 'description': 'From all DBS leads (2 per patient):\n\nLocal field potentials (LFPs) were measured intraoperatively during DBS implant. Features such as beta band power (10-30Hz), high-frequency oscillation power (200-400Hz, HFO), as well as the cross frequency coupling between beta band power and HFO (CFC) were extracted from the LFP recordings from all electrodes. Electrodes with the most beta band power, most HFOs, and most CFC were documented.\n\nAt 3 month post-op visit, the clinically programmed stimulation electrodes were documented, and were compared to the electrodes documented from the intraoperative LFP measures. Both matches in the exact contact and the row at which the contacts were in were documented and compared.'}], 'secondaryOutcomes': [{'measure': 'Number of DBS Leads With the Highest Side Effect Threshold at 3 Months That Were Consistent With Predictions Derived From LFPs After DBS Implant Procedure', 'timeFrame': 'LFPs were measured during DBS implant procedure, clinical programming were done at 3 month followup evaluation', 'description': 'From all DBS leads (2 per patient):\n\nLocal field potentials (LFPs) were measured intraoperatively during DBS implant. Features such as beta band power (10-30Hz), high-frequency oscillation power (200-400Hz, HFO), as well as the cross frequency coupling between beta band power and HFO (CFC) were extracted from the LFP recordings from all electrodes. Electrodes with the most beta band power, most HFOs, and most CFC were documented.\n\nAt 3 month post-op visit, the stimulation electrode that produced the largest side effect threshold (any side effect) were documented, and were compared to the electrodes with the largest beta band, HFO, and CFC power documented from the intraoperative LFP measures.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Parkinson']}, 'descriptionModule': {'briefSummary': 'The current study aims to explore the functional use of LFPs recorded intraoperatively for the optimization of a directional DBS lead programming\n\nAim-1: To determine whether intraoperative LFPs recorded from the segmented DBS electrode can predict the optimal stimulation parameters.\n\nAim-2: Compare the therapeutic window for stimulation delivered through directional and conventional leads and determine if the spatiospectral LFP patterns correlate with the presence of stimulation side effects.', 'detailedDescription': 'This is a feasibility study designed to evaluate the usefulness of intraoperative LFP recordings obtained from the implanted DBS lead to predict ideal stimulation parameters. Additionally this study will compare the therapeutic window for stimulation delivered through directional and conventional leads and determine if the spatiospectral LFP patterns correlate with the presence of stimulation side effects.\n\nApproximately 15 subjects will be enrolled in this clinical investigation. The clinical investigation will be conducted at 2 centers in the USA.\n\nSubjects participating in this clinical investigation will monitored during DBS implant procedure and programming. The expected duration of enrollment is 8 months. The total duration of the clinical investigation is expected to be 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In this study the investigators will explore the predictive capacity of LFPs recorded from STN. In total, 15 patients undergoing bilateral STN DBS will be enrolled for this investigation over a 1-year period. The current surgical case load at BCM supports this level of enrollment. The details of implantation procedures and blinded trial design are given in the following sections', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-70 years\n* Ability to provide informed consent\n* Diagnosis of idiopathic Parkinson's disease, and DBS consensus team review supporting the placement of STN DBS.\n\nExclusion Criteria:\n\n* Subject is not a surgical candidate;\n* In the Investigator's opinion the subject unable to tolerate multiple programming sessions within a single setting;\n* Subject unable to comply with the follow-up schedule"}, 'identificationModule': {'nctId': 'NCT03630302', 'acronym': 'INVENT', 'briefTitle': 'Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy', 'orgStudyIdInfo': {'id': 'CRD_931 INVENT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DBS', 'type': 'DEVICE', 'description': 'Deep Brain Stimulation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "CHI St. Luke's Health Baylor College of Medicine Med. Ctr.", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'University of Houston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}