Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-30 @ 9:45 PM
Study NCT ID:
NCT04043403
Status:
COMPLETED
Last Update Posted:
2025-10-15
First Post:
2019-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-28', 'size': 808112, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-10-10T17:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will have either the Percept PC system, or Summit RC+S system from Medtronic PLC implanted.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2019-07-30', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to Stimulation Condition', 'timeFrame': '3 Months', 'description': 'A Customized Adverse Events and Tolerability Questionnaire will measure the absence/presence and frequency of paresthesias, and muscle twitching relative to each stimulation condition'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to quality of life', 'timeFrame': '3 Months', 'description': "The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, and IV will:\n\n(I) Evaluate mentation, behavior, and mood (II) Evaluate a patient's activities of daily life (IV) Measure the presence/severity of dyskinesias and other complications of therapy over time"}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to speech', 'timeFrame': '6 Months', 'description': 'The Speech Intelligibility Test (SIT) will measure changes in speech related to each stimulation condition.'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] related to gait', 'timeFrame': '3 Months', 'description': 'The Freezing of Gait Questionnaire (FOG-Q) will be used to record changes in gait over time'}], 'secondaryOutcomes': [{'measure': 'Gait Parameters: Arrhythmicity', 'timeFrame': 'Collected up to 10 days every 3 months', 'description': 'Variability in stride time during a gait task'}, {'measure': 'Gait Parameters: Mean Shank Angular Velocity', 'timeFrame': 'Collected up to 10 days every 3 months', 'description': 'Average of the peak shank angular velocities of every stride during the gait task'}, {'measure': 'Gait Parameters: Mean Gait Cycle Time', 'timeFrame': 'Collected up to 10 days every 3 months', 'description': 'Average length of time of each stride during a gait task'}, {'measure': 'Percent Time Freezing', 'timeFrame': 'Collected up to 10 days every 3 months', 'description': 'The percentage of the gait task was a participant frozen'}, {'measure': "The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III", 'timeFrame': 'Collected up to 10 days every 3 months', 'description': 'Portion of the scale assesses the motor signs of PD. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 132.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Deep Brain Stimulation of the subthalamic nucleus (STN) has become a standard of care, FDA-approved treatment for Parkinson's disease, with stimulation delivered at a constant amplitude and voltage, operating in an open-loop fashion that does not respond to a patient's current state. Although gait deficits and freezing of gait may initially respond to continuous open-loop deep brain stimulation (olDBS) and medication, the symptoms often recur over time.\n\nThe episodic and predictable nature of FOG makes it well suited for adaptive DBS (aDBS) and a device that overcomes the limitations of traditional high frequency olDBS and is capable of adapting therapy either in the frequency or intensity domain transiently to treat FOG while also treating other PD signs such as tremor and bradykinesia.\n\nThe purpose of this study is to determine the feasibility of an adaptive DBS system, that responds to patient-specific neural and kinematic variables with customized DBS parameters."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinically-established PD\n* Meets criteria for STN DBS eligibility as part of patient's standard medical care or already implanted in the STN with Percept(TM) PC\n* The presence of complications of medication such as wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication due to these factors.\n* Ability and willingness to return for study visits, at the initial programming and after three, six and twelve months of DBS.\n* Age \\> 18\n* Freezing of gait questionnaire (FOG-Q) score ≥ 1 and/or gait sub-score (Item 3.10) of MDS- UPDRS III ≥ 1\n* Greater than or equal to 1.2 microVp between 8-35 Hz on either the LSTN or RSTN (Percept (TM) PC cohort only)\n\nExclusion Criteria:\n\n* Dementia\n* Untreated psychiatric disease\n* Hoehn and Yahr stage 5 on or off medication (non-ambulatory)\n* Age \\> 80\n* Major surgical morbidities such as severe hypertension, coagulopathy and certain metabolic conditions that might increase the risk of hemorrhage or other surgical complications\n* Presence of a cardiac pacemaker/defibrillator\n* Inability to understand/sign consent\n* Requires rTMS, ECT, MRI (Summit(R) RC+S cohort only), or diathermy\n* Are pregnant or lactating\n* Has a cranial metallic implant\n* History of seizures or epilepsy"}, 'identificationModule': {'nctId': 'NCT04043403', 'briefTitle': 'Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait Using Neural and Kinematic Feedback', 'orgStudyIdInfo': {'id': '52548'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device: Summit RC+S', 'description': "1. Open Loop DBS: Standard DBS therapy at a constant frequency and voltage\n2. Adaptive (Closed Loop) DBS: DBS that responds to neural or kinematic features of patient's current state\n3. Intermittent Open Loop DBS: Control for aDBS - DBS intensity or frequency changes in a manner that mimics aDBS but is pre-determined and open loop rather than being responsive to neural or kinematic signals.", 'interventionNames': ['Device: Open Loop DBS', 'Device: Adaptive (Closed Loop) DBS', 'Device: Intermittent Open Loop DBS']}, {'type': 'EXPERIMENTAL', 'label': 'Device: Percept PC', 'description': "1. Open Loop DBS: Standard DBS therapy at a constant frequency and voltage\n2. Adaptive (Closed Loop) DBS: DBS that responds to neural features of patient's current state", 'interventionNames': ['Device: Open Loop DBS', 'Device: Adaptive (Closed Loop) DBS']}], 'interventions': [{'name': 'Open Loop DBS', 'type': 'DEVICE', 'description': 'Standard DBS therapy at a constant frequency and voltage', 'armGroupLabels': ['Device: Percept PC', 'Device: Summit RC+S']}, {'name': 'Adaptive (Closed Loop) DBS', 'type': 'DEVICE', 'description': "DBS that responds to neural (Percept PC and Summit RC+S) or kinematic (Summit RC+S) features of patient's current state", 'armGroupLabels': ['Device: Percept PC', 'Device: Summit RC+S']}, {'name': 'Intermittent Open Loop DBS', 'type': 'DEVICE', 'description': 'Control for aDBS - DBS intensity or frequency changes in a manner that mimics aDBS but is pre-determined and open loop rather than being responsive to neural or kinematic signals.', 'armGroupLabels': ['Device: Summit RC+S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Helen M. Bronte-Stewart, MD,MSE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Helen M. Bronte-Stewart', 'investigatorAffiliation': 'Stanford University'}}}}