Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-27 @ 3:13 AM
Study NCT ID:
NCT03666533
Status:
COMPLETED
Last Update Posted:
2025-09-16
First Post:
2018-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcranial Direct Current Stimulation for Post-stroke Gait Rehab
Sponsor:
Organization:
Raw JSON
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Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham tDCS', 'description': 'sham tDCS plus gait training\n\nSham transcranial Direct Current Stimulation: Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Gait Speed From Baseline (Meters/Second)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS', 'description': 'active tDCS plus gait training\n\nActive transcranial Direct Current Stimulation: Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'sham tDCS plus gait training\n\nSham transcranial Direct Current Stimulation: Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '0.183', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.141', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to post treatment (after 5 weeks of treatment)', 'description': 'Gait speed will be calculated based on Ten Meter Walk Test', 'unitOfMeasure': 'meters/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post Treatment on Timed up and go (Seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS', 'description': 'active tDCS plus gait training\n\nActive transcranial Direct Current Stimulation: Active tDCS is combined with gait therapy. 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Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'sham tDCS plus gait training\n\nSham transcranial Direct Current Stimulation: Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '2.79', 'spread': '3.047', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '1.717', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to post treatment (after 5 weeks of treatment)', 'description': 'Functional gait measure where individuals walk under different conditions and are scored on a a 4 point scale for performance. 0-30 points; Higher score indicates better outcome', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post Treatment on Fugl Meyer Lower Limb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS', 'description': 'active tDCS plus gait training\n\nActive transcranial Direct Current Stimulation: Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'sham tDCS plus gait training\n\nSham transcranial Direct Current Stimulation: Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '2.26', 'spread': '1.996', 'groupId': 'OG000'}, {'value': '2.62', 'spread': '2.334', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to post treatment (after 5 weeks of treatment)', 'description': 'Motor control measure for lower limb after stroke, items rated on a scale of 0-2. A higher score indicates better outcome. score range is 0-34 points.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post Treatment on Gait Assessment and Intervention Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS', 'description': 'active tDCS plus gait training\n\nActive transcranial Direct Current Stimulation: Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'sham tDCS plus gait training\n\nSham transcranial Direct Current Stimulation: Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.42', 'spread': '2.219', 'groupId': 'OG000'}, {'value': '-2.86', 'spread': '2.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to post treatment (after 5 weeks of treatment)', 'description': 'Measure of gait coordination after stroke; lower score indicates better coordination; 0-62 points, with lower score indicating better outcome', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Asymmetry of Tibialis Anterior Muscle Motor Evoked Potentials From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS', 'description': 'active tDCS plus gait training\n\nActive transcranial Direct Current Stimulation: Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'sham tDCS plus gait training\n\nSham transcranial Direct Current Stimulation: Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline to after 5 weeks of treatment', 'description': 'Motor Evoked Potential (MEP) is a measure of corticospinal excitability using Transcranial Magnetic Stimulation. We collected maximum MEP from the paretic and non-paretic limbs. Asymmetry of paretic and non-paretic MEPs was calculated as follows: non-paretic minus paretic divided by a sum of paretic and non-paretic. It is expected that therapy reduces asymmetry caused by stroke. We report number of participants with reduced asymmetry of paretic and non-paretic tibialis anterior muscle Motor Evoked Potential.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active tDCS', 'description': 'active tDCS plus gait training\n\nActive transcranial Direct Current Stimulation: Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy'}, {'id': 'FG001', 'title': 'Sham tDCS', 'description': 'sham tDCS plus gait training\n\nSham transcranial Direct Current Stimulation: Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active tDCS', 'description': 'active tDCS plus gait training\n\nActive transcranial Direct Current Stimulation: Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy'}, {'id': 'BG001', 'title': 'Sham tDCS', 'description': 'sham tDCS plus gait training\n\nSham transcranial Direct Current Stimulation: Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62.5', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '67.7', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '65.2', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'years post stroke, mean (SD)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '3.4', 'groupId': 'BG000'}, {'value': '4.5', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '4.5', 'spread': '4.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'stroke type, Ischemic, n (count of participants)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-13', 'size': 160425, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-17T12:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'transcranial Direct Current Stimulation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2018-09-04', 'resultsFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2018-09-07', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-05-21', 'studyFirstPostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Gait Speed From Baseline (Meters/Second)', 'timeFrame': 'baseline to post treatment (after 5 weeks of treatment)', 'description': 'Gait speed will be calculated based on Ten Meter Walk Test'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Post Treatment on Timed up and go (Seconds)', 'timeFrame': 'baseline to post treatment (after 5 weeks of treatment)', 'description': 'Gait function measure where individuals rise from a chair, walk 3 meters, turn around and return to sitting in the chair'}, {'measure': 'Change From Baseline to Post Treatment in Functional Gait Assessment (Points)', 'timeFrame': 'baseline to post treatment (after 5 weeks of treatment)', 'description': 'Functional gait measure where individuals walk under different conditions and are scored on a a 4 point scale for performance. 0-30 points; Higher score indicates better outcome'}, {'measure': 'Change From Baseline to Post Treatment on Fugl Meyer Lower Limb', 'timeFrame': 'baseline to post treatment (after 5 weeks of treatment)', 'description': 'Motor control measure for lower limb after stroke, items rated on a scale of 0-2. A higher score indicates better outcome. score range is 0-34 points.'}, {'measure': 'Change From Baseline to Post Treatment on Gait Assessment and Intervention Tool', 'timeFrame': 'baseline to post treatment (after 5 weeks of treatment)', 'description': 'Measure of gait coordination after stroke; lower score indicates better coordination; 0-62 points, with lower score indicating better outcome'}, {'measure': 'Change in Asymmetry of Tibialis Anterior Muscle Motor Evoked Potentials From Baseline', 'timeFrame': 'baseline to after 5 weeks of treatment', 'description': 'Motor Evoked Potential (MEP) is a measure of corticospinal excitability using Transcranial Magnetic Stimulation. We collected maximum MEP from the paretic and non-paretic limbs. Asymmetry of paretic and non-paretic MEPs was calculated as follows: non-paretic minus paretic divided by a sum of paretic and non-paretic. It is expected that therapy reduces asymmetry caused by stroke. We report number of participants with reduced asymmetry of paretic and non-paretic tibialis anterior muscle Motor Evoked Potential.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gait therapy', 'transcranial Direct Current Stimulation (tDCS)', 'Neuroplasticity', 'walking ability', 'brain stimulation', 'virtual reality'], 'conditions': ['Stroke', 'Gait Impairment']}, 'referencesModule': {'references': [{'pmid': '40329808', 'type': 'DERIVED', 'citation': 'Pundik S, Skelly MM, McCabe JP, Salameh AI, Anderson T, Duncan KR, Hisel T, Carr SJA. Resting-State Functional Connectivity of Sensorimotor and Default Mode Networks and Lower Limb Performance in Chronic Stroke: A Cross-Sectional Study. Brain Behav. 2025 May;15(5):e70519. doi: 10.1002/brb3.70519.'}]}, 'descriptionModule': {'briefSummary': 'Stroke affects upwards of 800,000 Americans every year and has an enormous impact on the well-being of the American Veteran population with 6,000 new stroke admissions every year. Many of these stroke survivors are living with walking disabilities. Gait problems result in inability to function independently, high risk of falls and poor quality of life. Unfortunately, current gait rehabilitation treatments are limited and many stroke survivors do not achieve full recovery. Therefore, it is critical to develop new approaches to enhance gait rehabilitation methods. The investigators propose to evaluate a brain stimulation treatment called transcranial Direct Current Stimulation (tDCS) that can be added to physical therapy. tDCS has been applied for arm rehabilitation after stroke with positive results, but gait-related investigations are lacking. The investigators will test whether simultaneous tDCS and gait training produces greater improvement in walking abilities than gait training alone. Adjunct tDCS therapy may improve outcomes, and reduce cost of both rehabilitation and post-stroke care.', 'detailedDescription': 'Current rehabilitation methods fail to restore normal gait for many stroke survivors leading to dependence on others, recurrent falls, limitations in community ambulation and poor quality of life. The main objective of this study is to test both efficacy and neurophysiological mechanisms of a novel approach to treat persistent gait deficits after stroke with a combination of simultaneous non-invasive brain stimulation with transcranial Direct Current Stimulation (tDCS) and gait training. The investigators will enroll chronic stroke subjects (\\>6 months) with gait deficits. Subjects will be randomized to 10 sessions of either active tDCS+gait training or sham tDCS+gait training. Gait training will be accomplished in the treadmill-based Virtual Reality environment targeting longer single limb stance with the paretic limb. The primary outcome measure will be both gait speed and single limb stance duration. Other outcome measures will assess various components of gait-related functional domains. The study will also characterize neuroplastic brain changes in response to bihemispheric tDCS combined with gait training based on corticospinal excitability using motor evoked potentials and functional connectivity using resting state functional Magnetic Resonance Imaging (rs-fMRI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically and psychologically stable and at least 6 months after first ever unilateral stroke\n* Cognition sufficiently intact to give valid informed consent to participate\n* FMLE score \\>15; and ability to actively dorsiflex the paretic ankle in synergy (FMLE item II Flexor synergy-ankle dorsiflexion score 1).\n* Sufficient endurance to participate in the study\n\nExclusion Criteria:\n\n* Activity tolerance is insufficient to complete treadmill training\n* Inability to produce a trace contraction of ankle dorsiflexors in synergy\n* Normal ankle dorsiflexion/knee flexion on FMLE standing items (FMLE item IV score=4)\n* Stroke affecting both sides\n* Contraindications for rTMS according to the most recent TMS-use guidelines\n* Contraindications for MRI\n* Inability to understand English'}, 'identificationModule': {'nctId': 'NCT03666533', 'briefTitle': 'Transcranial Direct Current Stimulation for Post-stroke Gait Rehab', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Transcranial Direct Current Stimulation for Post-stroke Gait Rehab', 'orgStudyIdInfo': {'id': 'N2620-R'}, 'secondaryIdInfos': [{'id': '15036-H19', 'type': 'OTHER_GRANT', 'domain': 'Louis Stokes Cleveland VA Medical Center IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active tDCS', 'description': 'active tDCS plus gait training', 'interventionNames': ['Other: Active transcranial Direct Current Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'sham tDCS plus gait training', 'interventionNames': ['Other: Sham transcranial Direct Current Stimulation']}], 'interventions': [{'name': 'Active transcranial Direct Current Stimulation', 'type': 'OTHER', 'otherNames': ['tDCS'], 'description': 'Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy', 'armGroupLabels': ['Active tDCS']}, {'name': 'Sham transcranial Direct Current Stimulation', 'type': 'OTHER', 'otherNames': ['Sham tDCS'], 'description': 'Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy', 'armGroupLabels': ['Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-1702', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Louis Stokes VA Medical Center, Cleveland, OH', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Svetlana Pundik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Louis Stokes VA Medical Center, Cleveland, OH'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}