Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT01615718
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2012-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-invasive Neurostimulation in Parkinson's Disease
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2012-05-30', 'studyFirstSubmitQcDate': '2012-06-08', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Motor Function', 'timeFrame': 'Measured for approximately 2 months', 'description': "We will measure motor symptoms using the Unified Parkinson's Disease Rating Scale (UPDRS), bradykinesia tests and walking tests. We will assess the changes in these scales from baseline."}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'Measured for approximately 2 months', 'description': 'We will measure safety using a battery of electrophysiology, cognitive and neurological safety markers. We will use the Scales for Outcomes in PD-Cognitive (SCOPA-COg), the n-back working memory test, adverse effects questionnaire, electroencephalography (EEG) and a standardized neurological exam'}, {'measure': 'Neurophysiological Changes', 'timeFrame': 'Measured for approximately 2 months', 'description': 'We will also use transcranial magnetic stimulation (TMS) and Doppler Ultrasound to assess electrophysiology and cerebral bloodflow markers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['noninvasive stimulation', 'motor function', 'transcranial stimulation', 'transcranial ultrasound', 'brain stimulation'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "In this study, the investigators aim to investigate the effects of non-invasive neurostimulation - low-intensity transcranial electrical stimulation in conjunction with transcranial ultrasound (TUS)- on the motor symptoms associated with Parkinson's disease. The investigators want to see if there is a difference between active and sham stimulation on these motor symptoms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documentation of PD diagnosis from their clinician by either a letter or verification through their medical record\n* Research criteria of "possible" or "probable" PD, as defined by Gelb et al (Gelb D, Oliver E, Gilman S. Diagnostic Criteria for Parkinson Disease. Arch Neurol.1999;56:33-39)\\[1\\]\n* Age 40 or over;\n* Taking stable medications for at least 30 days\n\nExclusion Criteria:\n\n* Features suggestive of other causes of parkinsonism/Parkinson\'s-plus syndromes;\n* History of deep brain stimulation or ablation surgery, mass brain lesions;\n* History of schizophrenia, schizoaffective disorder, other psychosis, episode of bipolar illness, alcohol/drug abuse within the past year;\n* Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidal;\n* Contraindications to transcranial brain stimulation or TUS, i.e. metal in the head, implanted brain medical devices, etc;\n* Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure, pulmonary issues, or chronic obstructive pulmonary disease);\n* Pregnancy.\n* Epilepsy or disorders that increase likelihood of seizures including: moderate or severe traumatic brain injury, congenital birth defects leading to seizures, brain tumor, metabolism disorders associated with seizures, and nonlacunar stroke.'}, 'identificationModule': {'nctId': 'NCT01615718', 'briefTitle': "Non-invasive Neurostimulation in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': "Effects of Non-invasive Neurostimulation Methods on Motor Function in Parkinson's Disease Patients.", 'orgStudyIdInfo': {'id': '2012-p-001120'}, 'secondaryIdInfos': [{'id': '1R44NS080632-01', 'link': 'https://reporter.nih.gov/quickSearch/1R44NS080632-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Electrical Stim/Active Ultrasound', 'description': 'Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.', 'interventionNames': ['Procedure: low-intensity transcranial electrical stimulation', 'Procedure: transcranial ultrasound']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Electrical Stim/Sham Ultrasound', 'description': 'Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with sham transcranial ultrasound for 20 minutes.', 'interventionNames': ['Procedure: low-intensity transcranial electrical stimulation', 'Procedure: transcranial ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Electrical Stim/Sham Ultrasound', 'description': 'Subjects will undergo active low-intensity transcranial electrical stimulation in conjunction with sham (placebo) transcranial ultrasound for 20 minutes.', 'interventionNames': ['Procedure: low-intensity transcranial electrical stimulation', 'Procedure: transcranial ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sham Electrical Stim/Active Ultrasound', 'description': 'Subjects will undergo sham (placebo) low-intensity transcranial electrical stimulation in conjunction with active transcranial ultrasound for 20 minutes.', 'interventionNames': ['Procedure: low-intensity transcranial electrical stimulation', 'Procedure: transcranial ultrasound']}], 'interventions': [{'name': 'low-intensity transcranial electrical stimulation', 'type': 'PROCEDURE', 'description': 'Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for 20 minutes - however, during sham stimulation (placebo) the current will not be active for the full 20 minutes.', 'armGroupLabels': ['Active Electrical Stim/Active Ultrasound', 'Active Electrical Stim/Sham Ultrasound', 'Sham Electrical Stim/Active Ultrasound', 'Sham Electrical Stim/Sham Ultrasound']}, {'name': 'transcranial ultrasound', 'type': 'PROCEDURE', 'description': 'Subjects will undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.', 'armGroupLabels': ['Active Electrical Stim/Active Ultrasound', 'Active Electrical Stim/Sham Ultrasound', 'Sham Electrical Stim/Active Ultrasound', 'Sham Electrical Stim/Sham Ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02144', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Rehabilitation Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Timothy Wagner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Highland Instruments, Inc.'}, {'name': 'Felipe Fregni, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spaulding Rehabilitation Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}, {'name': 'Highland Instruments, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Felipe Fregni', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}