Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT03540134
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2018-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Convection Enhanced Delivery of CSF in DBS for Parkinson's
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'FUSbrain@virginia.edu', 'phone': '(434) 924-0451', 'title': 'Dr. Jeff Elias', 'organization': 'University of Virginia'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were recorded from the initial consent signing until the 6 month follow up visit.', 'description': 'At each visit patients are examined for any incidence of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Intracerebral Infusion of Autologous CSF', 'description': 'All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.\n\nIntracerebral Infusion of Autologous Cerebral Spinal Fluid: Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Head pain/Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Word finding difficulty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events That Are Related to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intracerebral Infusion of Autologous CSF', 'description': 'All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.\n\nIntracerebral Infusion of Autologous Cerebral Spinal Fluid: Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months postoperatively', 'description': "Safety will be determined by an evaluation of the incidence and severity of infusion-related side effects and complications from the first treatment day visit through the 6-month post-treatment time point. All AEs will be reported and categorized by investigators as definitely, probably, possibly, unlikely, or unrelated to the CSF infusion, and/or Parkinson's disease progression. Safety will be assessed by incidence and severity of AEs, including changes in physical examinations and neurological examinations, and the number of discontinuations due to AEs.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '% Change in Un-medicated UPDRS, Motor Subsection (Part III) From Baseline to 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intracerebral Infusion of Autologous CSF', 'description': 'All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.\n\nIntracerebral Infusion of Autologous Cerebral Spinal Fluid: Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.5', 'spread': '.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months postoperatively in comparison to baseline', 'description': 'The efficacy endpoint will be focused on determining the degree of change in motor symptoms as measured from the in-medicated UPDRS, motor subsection (Part III).', 'unitOfMeasure': 'percentage of UPDRS change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vd/Vi Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intracerebral Infusion of Autologous CSF', 'description': 'All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.\n\nIntracerebral Infusion of Autologous Cerebral Spinal Fluid: Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring'}], 'classes': [{'categories': [{'measurements': [{'value': '2.69', 'spread': '.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day of Surgery', 'description': 'The ratio of the volume of distribution (Vd) immediately following the infusion (Vi) with intraoperative 1.5T MRI, T2-weighted sequences to the volume of the infusion (Vi) will be calculated. Each volume is measured in microliters (uL). The distribution of the infusion by convective properties in a deep brain human nucleus (GPi or STN) will be determined by calculating the Vd/Vi ratio.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Baseline Levodopa Medication Equivalents (Milligrams)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intracerebral Infusion of Autologous CSF', 'description': 'All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.\n\nIntracerebral Infusion of Autologous Cerebral Spinal Fluid: Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring'}], 'classes': [{'categories': [{'measurements': [{'value': '1893.3', 'spread': '246.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'unitOfMeasure': 'Levodopa medication equivalents (milligr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life Assessment With PDQ-39 Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intracerebral Infusion of Autologous CSF', 'description': 'All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.\n\nIntracerebral Infusion of Autologous Cerebral Spinal Fluid: Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.75', 'spread': '30.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months postoperatively in comparison to baseline', 'description': 'The PDQ-39 questionnaire includes 39 quality of life questions rated on a scale of 0-4. 0 indicating least frequent (never) and 4 indicating most frequent (always). The mean change in the sum of the PDQ-39 questionnaire is being reported with a overall score of 0 being the best quality of life and a maximum score of 156 being the worst possible quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intracerebral Infusion of Autologous CSF', 'description': 'All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.\n\nIntracerebral Infusion of Autologous Cerebral Spinal Fluid: Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All subjects were recruited from the medical clinic.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intracerebral Infusion of Autologous CSF', 'description': 'All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.\n\nIntracerebral Infusion of Autologous Cerebral Spinal Fluid: Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], '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': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '63.25', 'spread': '13.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-08', 'size': 989177, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_003.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-16T09:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2018-04-11', 'resultsFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2018-05-25', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-16', 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events That Are Related to Treatment', 'timeFrame': '6 months postoperatively', 'description': "Safety will be determined by an evaluation of the incidence and severity of infusion-related side effects and complications from the first treatment day visit through the 6-month post-treatment time point. All AEs will be reported and categorized by investigators as definitely, probably, possibly, unlikely, or unrelated to the CSF infusion, and/or Parkinson's disease progression. Safety will be assessed by incidence and severity of AEs, including changes in physical examinations and neurological examinations, and the number of discontinuations due to AEs."}], 'secondaryOutcomes': [{'measure': '% Change in Un-medicated UPDRS, Motor Subsection (Part III) From Baseline to 6 Months', 'timeFrame': '6 months postoperatively in comparison to baseline', 'description': 'The efficacy endpoint will be focused on determining the degree of change in motor symptoms as measured from the in-medicated UPDRS, motor subsection (Part III).'}, {'measure': 'Vd/Vi Ratio', 'timeFrame': 'Day of Surgery', 'description': 'The ratio of the volume of distribution (Vd) immediately following the infusion (Vi) with intraoperative 1.5T MRI, T2-weighted sequences to the volume of the infusion (Vi) will be calculated. Each volume is measured in microliters (uL). The distribution of the infusion by convective properties in a deep brain human nucleus (GPi or STN) will be determined by calculating the Vd/Vi ratio.'}, {'measure': 'Baseline Levodopa Medication Equivalents (Milligrams)', 'timeFrame': 'Baseline'}, {'measure': 'Change in Quality of Life Assessment With PDQ-39 Questionnaire', 'timeFrame': '6 months postoperatively in comparison to baseline', 'description': 'The PDQ-39 questionnaire includes 39 quality of life questions rated on a scale of 0-4. 0 indicating least frequent (never) and 4 indicating most frequent (always). The mean change in the sum of the PDQ-39 questionnaire is being reported with a overall score of 0 being the best quality of life and a maximum score of 156 being the worst possible quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['DBS'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '36724759', 'type': 'DERIVED', 'citation': 'Moosa S, Bond AE, Wang TR, Farzad F, Asthagiri AR, Elias WJ. Stereotactic and Functional Neurosurgery Convection-Enhanced Delivery of Autologous Cerebrospinal Fluid Enhances Basal Ganglia Visualization during MRI-Guided Deep Brain Stimulation Surgery. Stereotact Funct Neurosurg. 2023;101(2):93-100. doi: 10.1159/000528738. Epub 2023 Feb 1.'}]}, 'descriptionModule': {'briefSummary': "This study will evaluate safety foremost but also the distribution and initial effectiveness of infusion-enhanced, MRI-guided DBS for patients with medication-refractory, Parkinson's disease", 'detailedDescription': "This is an open-label, single-arm, pilot study investigating the safety and feasibility of infusion-enhanced, MRI-guided DBS electrode placement. The investigators intend to enroll patients with Parkinson's disease and medically-refractory motor symptoms, who are already planned for MRI-guided DBS electrodes under general anesthesia. The hypothesis of the study is that a convective micro-infusion of autologous CSF will enhance the T2-weighted MRI visualization of the targeted nucleus during image-guided DBS surgery for Parkinson's disease. The investigators will record standard clinical measures of PD at baseline and 6 months following DBS surgery. The study will recruit patients at a rate of approximately one a month and will take less than two years to complete."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men and women, age 30 years and older\n2. Subjects with advanced PD who are scheduled for MRI-guided DBS surgery under general anesthesia\n3. Subjects who are able and willing to give informed consent and able to attend clinic visits through 6 months\n4. The target nucleus, GPi or STN, is visible on MRI so that it can be targeted for the study infusion and then for MRI-guided DBS\n\nExclusion Criteria:\n\n1. DBS surgery planned in the awake condition with microelectrode recordings and clinical testing\n2. Spinal pathology not amenable to lumbar puncture\n3. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia\n4. Legal incapacity or limited legal capacity as determined by the neuropsychologist\n5. Are participating or have participated in another clinical trial in the last 30 days\n6. Any illness that in the investigator's opinion preclude participation in this study."}, 'identificationModule': {'nctId': 'NCT03540134', 'briefTitle': "Convection Enhanced Delivery of CSF in DBS for Parkinson's", 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Convection Enhanced Delivery of Autologous Cerebral Spinal Fluid Improves MRI Visualizations of Basal Ganglion Nuclei During Deep Brain Stimulation Surgery', 'orgStudyIdInfo': {'id': 'IRB-HSR #20457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intracerebral Infusion of Autologous CSF', 'description': 'All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.', 'interventionNames': ['Device: Intracerebral Infusion of Autologous Cerebral Spinal Fluid']}], 'interventions': [{'name': 'Intracerebral Infusion of Autologous Cerebral Spinal Fluid', 'type': 'DEVICE', 'description': 'Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring', 'armGroupLabels': ['Intracerebral Infusion of Autologous CSF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'William J Elias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeff Elias, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurological Surgery', 'investigatorFullName': 'Jeff Elias, MD', 'investigatorAffiliation': 'University of Virginia'}}}}