Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-01-26 @ 6:02 AM
Study NCT ID:
NCT02134795
Status:
TERMINATED
Last Update Posted:
2025-05-02
First Post:
2014-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rblack@scionneurostim.com', 'phone': '(919) 260-5528', 'title': 'Dr. Robert Black', 'organization': 'Scion NeuroStim'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study did not achieve full enrollment and was, therefore, halted. This occurred before participants were able to complete outcomes measures, and, therefore, prevented outcome analysis.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Caloric Vestibular Stimulation (CVS)', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Motor UPDRS Score (Unified Parkinson's Disease Rating Scale)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Vestibular Stimulation (CVS)', 'description': "Mild to moderate Parkinson's disease subjects will up to 3 sessions of 19 minutes each with the TNM Device during as many as 2 study visits: 2 sessions separated by 1 hour during the 1st study visit and 1 CVS session during a 2nd study visit.\n\nTNM Device: The noninvasive device is worn like a music headset and the patient lies back on a wedge pillow while the device is active. Each session lasts under 20 minutes."}], 'timeFrame': 'Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline', 'description': 'A motor score prior to use of the device will be established (time zero), the motor test will be repeated after the first use of the device (times 25, 50, and 75 minutes), and then after a second use of the device (times 100, 130, 160 and 220). Any changes in motor scores at the various time points will be noted. A videotape of the motor UPDRS examination will be obtained at baseline and during the final test.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was halted early before any of the participants could complete this endpoint. Therefore, there is no outcome data to analyze.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Caloric Vestibular Stimulation (CVS)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Caloric Vestibular Stimulation (CVS)', 'description': 'ThermoNeuroModulation (TNM) device with a standardized active CVS waveform will be used for all patients. The device will be used twice for \\~19 minutes each time. There will be a gap of roughly 1 hour between the two device applications.\n\nThe device is worn like a music headset and the patient lies on a wedge pillow while the device is active. Each session lasts under 20 minutes.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Unknown', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'The study aimed to enroll 10 patients but only enrolled 6 total. Instead of keeping the study open, it was terminated early with incomplete results.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2014-05-06', 'resultsFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2014-05-07', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-30', 'studyFirstPostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Motor UPDRS Score (Unified Parkinson's Disease Rating Scale)", 'timeFrame': 'Changes in motor score at 25, 50, 75, 100, 130, 160 and 220 minutes relative to baseline', 'description': 'A motor score prior to use of the device will be established (time zero), the motor test will be repeated after the first use of the device (times 25, 50, and 75 minutes), and then after a second use of the device (times 100, 130, 160 and 220). Any changes in motor scores at the various time points will be noted. A videotape of the motor UPDRS examination will be obtained at baseline and during the final test.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's disease"], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "This is a single-center, open label study evaluating the acute effect of caloric vestibular stimulation on UPDRS motor scores in Parkinson's Disease patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient should have a UPDRS motor score of 14 (off medication) or higher (mild to moderate)\n* Patient should have a Hoehn \\& Yahr staging of 1 to 3 (mild to moderate)\n* Patient must be an adult (18 years of age or older)\n\nExclusion Criteria:\n\n* Women who are pregnant or nursing\n* have a history of significant cardiovascular disease (no pacemakers)\n* have a history of unstable mood disorder or unstable anxiety disorder or psychosis\n* use a hearing aid\n* have a cochlear implant\n* have been diagnosed with neurological disease other than Parkinson's disease. No atypical parkinsonism.\n* have a diagnosed vestibular dysfunction\n* abuse alcohol or other drugs\n* have had eye surgery within the previous three months or ear surgery within the previous six months\n* have active ear infections or a perforated tympanic membrane\n* have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial"}, 'identificationModule': {'nctId': 'NCT02134795', 'briefTitle': "A Pilot Study of a Non-Invasive Neuromodulation Device for Treatment of Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Scion NeuroStim'}, 'orgStudyIdInfo': {'id': 'Pro00053320'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caloric Vestibular Stimulation (CVS)', 'description': "Mild to moderate Parkinson's disease subjects will up to 3 sessions of 19 minutes each with the TNM Device during as many as 2 study visits: 2 sessions separated by 1 hour during the 1st study visit and 1 CVS session during a 2nd study visit.", 'interventionNames': ['Device: TNM Device']}], 'interventions': [{'name': 'TNM Device', 'type': 'DEVICE', 'description': 'The noninvasive device is worn like a music headset and the patient lies back on a wedge pillow while the device is active. Each session lasts under 20 minutes.', 'armGroupLabels': ['Caloric Vestibular Stimulation (CVS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scion NeuroStim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}