Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT05968703
Status:
RECRUITING
Last Update Posted:
2025-05-30
First Post:
2023-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All participants will receive the interventional treatment. Two different surgical trajectories will be used for placing the leads in the NBM. Half the cohort will be randomized to each trajectory.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2023-07-27', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Any untoward medical occurrence that occurs during this study whether or not considered related to the study device, study procedures, or study requirements that is identified or worsens during the duration of the study'}, {'measure': 'Swing Time Coefficient of Variation', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Swing time variability will be measured using the dual force plates in the SIP task and IMUs for TBC. It is defined as the mean swing time coefficient of variation (CV) of both legs.'}], 'secondaryOutcomes': [{'measure': 'Percent Time Freezing', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Duration of freezing episodes during SIP will be measured using IMUs and force plates using a validated offline algorithm.'}, {'measure': 'Stride Time Coefficient of Variation', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Stride time coefficient of variation will be measured using the dual force plates in the SIP task and IMUs. Stride time coefficient of variation is defined as the mean stride time coefficient of variation (CV) of both legs. A greater stride time CV is indicative of less rhythmic gait/stepping.'}, {'measure': 'Shank Angular Velocity', 'timeFrame': 'From baseline to 1 year into treatment', 'description': "Shank angular velocity will be measured from IMUs work on the participant's leg/ankle. Reductions in this value are indicative of FOG and gait impairment."}, {'measure': 'Tapping Speed', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'The interstrike-interval of alternating tapping will be measured using an engineered piano keyboard. A higher interstrike-interval indicates slower tapping'}, {'measure': 'Tapping Rhythmicity', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'The variability of the interstrike-interval of alternating tapping, as quantified by the coefficient of variation, will be measured using an engineered piano keyboard. A higher coefficient of variation indicates worse rhythmicity'}, {'measure': 'MDS-UPDRS III Score', 'timeFrame': 'From baseline to 1 year into treatment', 'description': "PD symptoms will be assessed clinically using the MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Section III. This is a motor examination to evaluate speech, facial expression, tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements, rapid alternating movement of hands, leg agility, arising from chair, posture, gait, freezing of gait, posture, body bradykinesia, and postural stability. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 132."}, {'measure': 'SAT Score', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Each trial of the SAT will be categorized as a Hit (H), Miss (M), or False Alarm (FA). The SAT score is defined as ((H - FA) / \\[2× (H + FA) - (H + FA)2\\]), which ranges from - 1.0 (100% incorrect performance; all misses and false alarms) to +1.0 (100% correct performance; all hits and correct rejections).'}, {'measure': 'Percent False Positives', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'The percent of false positives during the SAT.'}, {'measure': 'Percent Misses', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'The percent of misses of total trials during the SAT'}, {'measure': 'Average + standard deviation of response time', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'The average and standard deviation of the response time during the SAT.'}, {'measure': 'Goal-directed focus of attention', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Hit rate during the first minute in the no- distractor condition for the CTET.'}, {'measure': 'Sustained attention', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Hit rate change slope in no-distractor condition for the CTET.'}, {'measure': 'Distractibility', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Hit rate difference between no-distractor and distractor conditions for the CTET.'}, {'measure': "Parkinson's Disease - Cognitive Rating Scale (PD-CRS)", 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Cognitive scale composed of 9 tasks that assesses the full range of cognitive dysfunction in PD. It is a scale of 0 to 134, with 134 being the best score.'}, {'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Total score to assess of this rapid screening test of different cognitive domains. It is a scale of 0 to 30, with 30 being the best score.'}, {'measure': 'Trails A', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'The time it takes to complete the task and errors.'}, {'measure': 'Trails B', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'The time it takes to complete the task and errors.'}, {'measure': 'Symbol Digit Modalities (SDMT) Oral and Written', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'The summation of the number of correct substitutions within the 90 second interval.'}, {'measure': 'visual puzzles from the Wechsler Adult Intelligence Scale-IV (WAIS-IV)', 'timeFrame': 'From baseline to 1 year into treatment', 'description': "Percentile of performance on visual puzzles for participant's demographic."}, {'measure': 'Judgement of Line Orientation', 'timeFrame': 'From baseline to 1 year into treatment', 'description': "Percentile of performance on judgement of line orientation for participant's demographic."}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'From baseline to 1 year into treatment', 'description': "Total score on questionnaire regarding participant's mood the last 2 weeks. The scale ranges from 0 to 27 with a score of 27 indicating the most severe symptoms."}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'From baseline to 1 year into treatment', 'description': "Total score on questionnaire regarding participant's anxiety the last two weeks.The scale ranges from 0 to 21 with a score of 21 indicating the most severe symptoms."}, {'measure': 'MDS-UPDRS I', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Total score evaluating the non-motor aspects of experiences of daily living. It is a scale from 0 to 52 with 52 being the most severe symptoms.'}, {'measure': 'MDS-UPDRS II', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Total score evaluating the motor aspects of experiences of daily living. It is a scale from 0 to 52 with 52 being the most severe symptoms.'}, {'measure': 'MDS-UPDRS IV', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Total score of motor complications experienced by the participant. It is a scale from 0 to 24 with 24 being the most severe symptoms.'}, {'measure': 'Neuropsychiatric Inventory (NPI)', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Total score for symptom severity and distress via questionnaire. It is a scale from 0 to 60 with 60 indicating worse symptoms.'}, {'measure': "Parkinson's Disease Questionnaire-39 (PDQ-39)", 'timeFrame': 'From baseline to 1 year into treatment', 'description': "Total score for Parkinson's disease-specific health related quality over the last month across 8 quality of life dimensions assessed via questionnaire. Score ranges from 0 to 100 with 100 indicating more symptoms and problems."}, {'measure': 'Caregiver Burden Assessment', 'timeFrame': 'From baseline to 1 year into treatment', 'description': 'Total score on caregiver self-report to assess the stress-levels of family caregivers. It is a scale from 0 to 88 with higher scores indicating greater or worse burden.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['deep brain stimulation', 'cognition', 'DBS', "parkinson's disease"], 'conditions': ["Parkinson's Disease", 'Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to evaluate the safety and tolerability of a novel deep brain stimulation (DBS) of the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM) to treat cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. The main question it aims to answer is:\n\nIs a combined deep brain stimulation approach targeting the STN and NBM with four DBS leads safe and tolerable for cognitive and cognitive-motor symptoms in individuals with Parkinson's disease with Mild Cognitive Impairment. Ten participants are anticipated to be enrolled.\n\nParticipants will undergo a modification of the traditional STN DBS approach for motor symptoms of PD. In addition to the two leads placed within the STN, two additional leads will be placed with the NBM for treatment of cognitive and cognitive-motor symptoms. Novel stimulation patterns will be used within the NBM to target cognitive and cognitive-motor symptoms using an investigational software. Participants will be followed over two years while receiving this therapy with assessments at baseline and every six months. Assessments will include a combination of neuropsychological evaluations, cognitive assessments, motor tasks (including gait/walking), and questionnaires to evaluate the treatment. Two different surgical trajectories will be used, with half the cohort randomized to each group. This will allow comparison of the impact of surgical trajectory on the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease (PD)\n* Approved (or planning on) for subthalamic nucleus (STN) deep brain stimulation (DBS)\n* Willingness to withdraw from clinical medication regimen when necessary for research visits\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Dementia\n* Unstable medical, psychiatric conditions including significant untreated depression, history of suicidal attempt, or current suicide ideation\n* History of seizures\n* Pregnant\n* Requires MRI\n* Unable to walk 100 feet without an assistive device"}, 'identificationModule': {'nctId': 'NCT05968703', 'briefTitle': "Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': "Neurostimulation of the Nucleus Basalis of Meynert for the Cognitive-Motor Syndrome in Parkinson's Disease", 'orgStudyIdInfo': {'id': '70608'}, 'secondaryIdInfos': [{'id': 'UG3NS128150', 'link': 'https://reporter.nih.gov/quickSearch/UG3NS128150', 'type': 'NIH'}, {'id': 'UH3NS128150', 'link': 'https://reporter.nih.gov/quickSearch/UH3NS128150', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vertical Nuclear Trajectory', 'description': 'Participants will receive combined STN + NBM DBS. The lead placed within the NBM will use a vertical trajectory targeting the nucleus itself.', 'interventionNames': ['Device: Combined STN+NBM DBS']}, {'type': 'EXPERIMENTAL', 'label': 'Lateral NBM Bundle Trajectory', 'description': 'Participants will receive combined STN + NBM DBS. The lead placed within the NBM will use a lateral trajectory targeting the lateral efferent bundle from the NBM', 'interventionNames': ['Device: Combined STN+NBM DBS']}], 'interventions': [{'name': 'Combined STN+NBM DBS', 'type': 'DEVICE', 'description': 'This intervention is a 4-lead deep brain stimulation approach targeting the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM)', 'armGroupLabels': ['Lateral NBM Bundle Trajectory', 'Vertical Nuclear Trajectory']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'bronte-stewart-lab@stanford.edu', 'phone': '650-723-6709'}], 'facility': 'Stanford Neuroscience Health Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'bronte-stewart-lab@stanford.edu', 'phone': '650-723-6709'}], 'overallOfficials': [{'name': 'Helen M Bronte-Stewart, MD MSE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'The IPD is anticipated to be available in approximately three months after study completion', 'ipdSharing': 'YES', 'description': 'De-identified data will be uploaded to the Data Archive for the BRAIN Initiative (DABI).', 'accessCriteria': 'DABI is openly available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helen M. Bronte-Stewart', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology', 'investigatorFullName': 'Helen M. Bronte-Stewart', 'investigatorAffiliation': 'Stanford University'}}}}