Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-29 @ 8:12 AM
Study NCT ID:
NCT04904068
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-06
First Post:
2021-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Neuroimaging 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-11-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2021-02-18', 'studyFirstSubmitQcDate': '2021-05-21', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional MRI activity during a motor task', 'timeFrame': 'Baseline', 'description': 'Functional MRI activity during isolated/coordinated movements of the upper and lower limbs'}], 'secondaryOutcomes': [{'measure': "Movement Disorder Society Unified Parkinson's Disease Rating Scale", 'timeFrame': 'Baseline', 'description': 'Only the motor section will be scored. Maximum points: 84 (the higher the score, the more severe the motor symptoms)'}, {'measure': 'Kinesia One', 'timeFrame': 'Baseline', 'description': "Instrumented measures of motor dysfunction in Parkinson's disease. Maximum points: 72 (the higher the score, the more severe the motor symptoms)"}, {'measure': 'Timed Up and Go', 'timeFrame': 'Baseline', 'description': 'Mobility test (instrumented). Measures: duration (s), lean angle during sit/stand (degrees), turning duration (s) and turning angle (degrees)'}, {'measure': '360-Degree Turn Test', 'timeFrame': 'Baseline', 'description': 'Instrumented test measuring dynamic balance. Measures: turning angle (degrees), turning duration (s), turning velocity (degrees/s)'}, {'measure': 'Five Times Sit to Stand', 'timeFrame': 'Baseline', 'description': 'Instrumented test measuring ability to perform transitional movements (i.e., get up from a chair). Measures: Duration (s), duration of the different phases (sitting/standing) (s), lean angle during the two phases (sitting/standing) (degrees)'}, {'measure': 'The Modified Clinical Test of Sensory Interaction and Balance (mCTSIB)', 'timeFrame': 'Baseline', 'description': 'Instrumented test assessing balance under different test conditions (eyes open/closed on firm/foam surface). Measures of postural sway: sway area (m\\^2/s\\^4), jerk (m\\^2/s\\^5), mean velocity (m/s), path length (m/s\\^2)'}, {'measure': '2-Minute Walking Test', 'timeFrame': 'Baseline.', 'description': 'Instrument test assessing gait under three different conditions: 1) self-selected/normal speed, 2) self-selective/normal speed + cognitive task, 3) fast speed. Measures calculated for each condition/side of body: cadence (steps/min), double support (%GCT), gait cycle duration (s), gait speed (m/s), lateral step variability (cm), toe off angle (degrees), foot strike angle (degrees), turn velocity (degrees/s), upper limb range of motion (degrees), arm swing velocity (degrees/s).'}, {'measure': 'Purdue Pegboard Test', 'timeFrame': 'Baseline', 'description': 'Test measuring dexterity by counting the number of pegs placed on the pegboard during a given time.'}, {'measure': 'Grooved Pegboard', 'timeFrame': 'Baseline', 'description': 'Test measuring dexterity by counting how long it takes to place a given number of pegs on the pegboard.'}, {'measure': 'Montreal Cognitive Assessment Test', 'timeFrame': 'Baseline', 'description': 'Test measuring global cognitive function. Maximum points: 30 (the higher the score, the better the cognitive function)'}, {'measure': 'Brief Test of Attention', 'timeFrame': 'Baseline', 'description': 'Test measuring attention. Two sections are used that evaluate attention during reading of lists of letters and numbers. Maximum points across the two sections: 20 (the higher the score, the better the attention)'}, {'measure': 'Beck Depression Inventory II', 'timeFrame': 'Baseline', 'description': 'Questionnaire measuring depression. Maximum points: 63 (high score indicates depression)'}, {'measure': "Parkinson's Disease Questionnaire (PDQ-39)", 'timeFrame': 'Baseline', 'description': 'Questionnaire measure health-related quality of life. Eight dimensions ranging from 0-100 (the higher the score, the worse the quality of life)'}, {'measure': 'Schwab and England Activities of Daily Living Scale', 'timeFrame': 'Baseline', 'description': 'Questionnaire on ability to complete daily task. 10% increments with 100% meaning an individual is completely independent when it comes to completing daily activities'}, {'measure': 'Rapid Eye Movement Behavior Disorder Questionnaire', 'timeFrame': 'Baseline', 'description': 'Questionnaire measuring sleep behavior. Maximum points: 13 (a high score is indicative of RBD sleep disorder)'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': 'Baseline', 'description': 'Questionnaire measuring sleepiness. Maximum points: 24 (high score indicates sleepiness)'}, {'measure': 'University of Pennsylvania Smell Identification Test', 'timeFrame': 'Baseline', 'description': 'Test measuring sense of smell. Maximum points: 40 (the higher the score, the more normal the smell)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease', 'Healthy Aging']}, 'descriptionModule': {'briefSummary': "The study uses magnetic resonance imaging (MRI) to better understand changes in the brain underlying motor symptoms affecting upper and lower limbs in Parkinson's disease.", 'detailedDescription': "There is a tremendous need to improve the understanding of the pathophysiology underlying motor symptoms in Parkinson's disease in order to optimize existing treatment options/develop new therapies. This study seeks to further the understanding of impaired movement in Parkinson's disease by examining brain changes and how these relate to changes in motor behavior.\n\nThe study uses magnetic resonance imaging (MRI), a noninvasive imaging technique that does not include X-rays. MRI will assess brain activity in response to simple and coordinated movements of the upper and lower limbs that participants have to perform inside the MRI scanner. Motor and cognitive function outside the scanner using various clinical and behavioral tests will also be assessed. The study includes 1 visit to the University of Delaware."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Open to local community as well as residents in DE or other nearby states willing to travel to the University of Delaware for the study.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A clinical diagnosis of Parkinson's disease\n* No neurological disorders if interested in participating as a control participant\n* Must be capable of providing informed consent\n* Must be eligible to receive a brain MRI\n\nExclusion Criteria:\n\n* A secondary movement disorder diagnosis in addition to Parkinson's disease\n* Dementia\n* Medical conditions that may make one ineligible for receiving a brain MRI\n* Inability to provide informed consent\n* Control/healthy group: neurological disorders\n* Control/healthy group: cannot walk without an assistive device/mobility problems"}, 'identificationModule': {'nctId': 'NCT04904068', 'briefTitle': "Functional Neuroimaging in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Delaware'}, 'officialTitle': "Imaging the Motor System in Parkinson's Disease", 'orgStudyIdInfo': {'id': '1407867'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Parkinson's disease", 'description': "Individuals with a clinical diagnosis of Parkinson's disease."}, {'label': 'Healthy', 'description': 'Healthy individuals with no known neurological disorders.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'University of Delaware', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}], 'overallOfficials': [{'name': 'Roxana G Burciu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Delaware'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Delaware', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Roxana Burciu', 'investigatorAffiliation': 'University of Delaware'}}}}