Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-22 @ 4:13 PM
Study NCT ID:
NCT03750903
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2018-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Aging on Cortical Excitability and Motor Learning
Sponsor:
Organization:
Raw JSON
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[{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aerobic Exercise', 'description': 'Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.\n\nAerobic Exercise: Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.'}, {'id': 'OG001', 'title': 'Stretching and Balance Training', 'description': 'Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.\n\nStretching and Balance Training: Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and12 weeks', 'description': 'Measuring changes in dynamic magnetic resonance spectroscopy of primary motor cortex during motor learning.', 'unitOfMeasure': 'ppm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '4 participants in the Aerobic exercise group and 10 participants in the Stretching and Balance Training group did not complete the 12 week follow up assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aerobic Exercise', 'description': 'Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.\n\nAerobic Exercise: Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.'}, {'id': 'FG001', 'title': 'Stretching and Balance Training', 'description': 'Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.\n\nStretching and Balance Training: Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aerobic Exercise', 'description': 'Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.\n\nAerobic Exercise: Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.'}, {'id': 'BG001', 'title': 'Stretching and Balance Training', 'description': 'Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.\n\nStretching and Balance Training: Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.88', 'groupId': 'BG000', 'lowerLimit': '66', 'upperLimit': '76'}, {'value': '71.24', 'groupId': 'BG001', 'lowerLimit': '65', 'upperLimit': '80'}, {'value': '70.02', 'groupId': 'BG002', 'lowerLimit': '65', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-30', 'size': 232731, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-26T09:31', 'hasProtocol': True}, {'date': '2021-11-26', 'size': 203840, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-09-23T12:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two group parallel design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2018-11-20', 'resultsFirstSubmitDate': '2024-12-03', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-01', 'studyFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnetic Resonance Spectroscopy', 'timeFrame': 'Baseline and12 weeks', 'description': 'Measuring changes in dynamic magnetic resonance spectroscopy of primary motor cortex during motor learning.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aging'], 'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The objective of the current proposal is to identify 1) how aging-related changes in GABAergic cortical inhibition affect motor performance, and 2) how aerobic exercise may improve inhibitory function and facilitate motor learning.', 'detailedDescription': "The current proposal seeks quantify neural inhibition using magnetic resonance spectroscopy (MRS) and transcranial magnetic stimulation (TMS) in older Veterans to identify how each measures contributes to aging-related changes in motor performance. Currently, over 56% (11.8 million) of Veterans are over age 60. Recent research has shown that aging is associated with decreased cortical inhibition and impaired hand motor function. However, this loss of inhibition is not an inescapable consequence of aging. The investigators' previous work that healthy older adults who engage in regular physical activity show increased cortical inhibition and improved dexterity as compared to their sedentary age cohort. This indicates that aerobic training may reverse aging related changes in cortical inhibition and alteration of tonic levels of cortical excitability can have a powerful impact on motor performance in the aging brain. In the current proposal, the investigators will enroll older adults to assess how different measurements (TMS and MRS) of the dominant inhibitory neurotransmitter in the brain - GABA differ in relation to motor control. During the MRS scan, participants will perform a motor learning task to assess change in GABA level throughout the acquisition session. These data will be compared with measures of cortical inhibition using TMS to quantify neurotransmitter receptor activity with respect to aging-related changes in motor performance. The investigators will also be comparing the effects of an aerobic exercise intervention as compared to a contact matched stretching control. The investigators believe this project is the first inquiry of its kind and will have an important impact in the understanding of aging-related neurophysiological changes in the brain and how it can remediate associated behavioral declines."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* living persons aged 50-85\n\nExclusion Criteria:\n\n* unmanaged diabetes\n* participants completing vigorous exercise per week\n* participants whose profession requires vigorous physical labor\n* contraindication to magnetic resonance imaging'}, 'identificationModule': {'nctId': 'NCT03750903', 'acronym': 'ACE', 'briefTitle': 'Effect of Aging on Cortical Excitability and Motor Learning', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Effects of Aging on Cortical Excitability During Motor Learning', 'orgStudyIdInfo': {'id': 'E2619-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic Exercise', 'description': 'Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.', 'interventionNames': ['Behavioral: Aerobic Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stretching and Balance Training', 'description': 'Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.', 'interventionNames': ['Behavioral: Stretching and Balance Training']}], 'interventions': [{'name': 'Aerobic Exercise', 'type': 'BEHAVIORAL', 'otherNames': ['AE; Exercise'], 'description': 'Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.', 'armGroupLabels': ['Aerobic Exercise']}, {'name': 'Stretching and Balance Training', 'type': 'BEHAVIORAL', 'otherNames': ['BAL; Balance'], 'description': 'Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.', 'armGroupLabels': ['Stretching and Balance Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30033-4004', 'city': 'Decatur', 'state': 'Washington', 'country': 'United States', 'facility': 'Atlanta VA Medical and Rehab Center, Decatur, GA', 'geoPoint': {'lat': 48.50038, 'lon': -122.81962}}], 'overallOfficials': [{'name': 'Joe R. Nocera, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlanta VA Medical and Rehab Center, Decatur, GA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}