Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-01-05 @ 5:19 PM
Study NCT ID:
NCT03178903
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2017-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
tDCS for Increasing Exercise Adherence in Depressed Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ana_Abrantes@Brown.edu', 'phone': '4014556440', 'title': 'Ana M. Abrantes, Ph.D.', 'organization': 'Butler Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'It does not differ from clinicaltrials.gov definitions', 'eventGroups': [{'id': 'EG000', 'title': 'tDCS and Aerobic Exercise', 'description': 'Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.\n\ntDCS: Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.\n\nAerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Sham tDCS and Aerobic Exercise', 'description': 'Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.\n\nSham tDCS: Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.\n\nAerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 1, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'knee injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Psychiatric Inpatient Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Medical Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Physical Activity Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS and Aerobic Exercise', 'description': 'Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.\n\ntDCS: Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.\n\nAerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.'}, {'id': 'OG001', 'title': 'Sham tDCS and Aerobic Exercise', 'description': 'Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.\n\nSham tDCS: Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.\n\nAerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '17.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.87', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.678', 'pValueComment': 'p\\<.05 was the a priori threshold for statistical significance.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Covarying for baseline depressive symptoms and MVPA.'}], 'paramType': 'MEAN', 'timeFrame': '8 week assessment', 'description': 'Accelerometry-based moderate-to-vigorous physical activity (MVPA)', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The numbers analyzed include only individuals that provided valid wear-time data on the primary outcome measure, using accelerometry. Specifically, only participants that provided 3 days of 8 hours/day valid wear time were included in the analysis of the primary outcome.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'tDCS and Aerobic Exercise', 'description': 'Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.\n\ntDCS: Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.\n\nAerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.'}, {'id': 'FG001', 'title': 'Sham tDCS and Aerobic Exercise', 'description': 'Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.\n\nSham tDCS: Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.\n\nAerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'tDCS and Aerobic Exercise', 'description': 'Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.\n\ntDCS: Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.\n\nAerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.'}, {'id': 'BG001', 'title': 'Sham tDCS and Aerobic Exercise', 'description': 'Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.\n\nSham tDCS: Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.\n\nAerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '50.1', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '49.5', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Depressive Symptoms', 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '21.8', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '22.3', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline depressive symptoms were collected using the Center for Epidemiological Studies--Depression (CES-D) measure. The range of scores is 0 to 60. Scores above 15 indicate clinical depression. Higher scores indicate higher levels of depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Minutes of Moderate-to-Vigorous Physical Activity (MVPA)', 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '20.0', 'spread': '14.4', 'groupId': 'BG001'}, {'value': '17.4', 'spread': '13.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes per day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-21', 'size': 367515, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-01-02T10:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-31', 'studyFirstSubmitDate': '2017-05-10', 'resultsFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-31', 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity Levels', 'timeFrame': '8 week assessment', 'description': 'Accelerometry-based moderate-to-vigorous physical activity (MVPA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Physical Activity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the efficacy of tDCS (transcranial direct current stimulation) for increasing exercise adherence among low active individuals with elevated depressive symptoms. The investigators expect that this project will contribute much needed knowledge about the role that tDCS can play in changing the affective experience of exercise.', 'detailedDescription': 'Exercise adherence is a significant public health problem. Affective experiences during exercise predict long-term physical activity (PA) levels. Therefore, approaches to improving the affective experience of exercise are both important and likely to have high impact. This may be particularly true among individuals with elevated depressive symptoms due to their tendency toward more negative and less positive affect. tDCS is a noninvasive brain stimulation approach with a growing body of literature supporting its effects on cognitive and emotional processing in varied populations, including some support for those with depression. In addition, there is recent increased interest in utilizing tDCS in the context of exercise (see above) and in obesity prevention. While the effects of tDCS on behavioral and cognitive functioning are still developing, promising findings have emerged for tDCS used in repeated combination with a behavioral or cognitive intervention. Given that tDCS is relatively safe, inexpensive, and portable, individuals who struggle with enjoying exercise could be afforded a practical option for increasing and maintaining physical activity levels.\n\nWe propose to conduct a pilot randomized controlled trial of tDCS versus sham delivered 3x/week for 8 weeks in the context of a supervised aerobic exercise (AE) program among 72 low-active individuals with elevated depressive symptoms. Follow-up assessments will be conducted at end of treatment, 3, and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be between 18 and 65 years of age\n* be low active\n* have elevated levels of depressive symptoms\n* interested in starting an exercise program in the next month\n\nExclusion Criteria:\n\n* history of mania or hypomania\n* current psychotic disorder\n* current DSM-5 diagnosis of an eating disorder\n* DSM-5 moderate and severe substance use disorder\n* current suicidality or homicidality\n* current DSM-5 diagnosis of major depressive disorder that is not currently being treated with pharmacotherapy or psychotherapy\n* physical disabilities or medical problems that would prevent participation in moderate intensity exercise or may be contraindicated for tDCS\n* current pregnancy or intent to become pregnant during the next 8 weeks\n* pacemaker or metal implanted in the cranial cavity'}, 'identificationModule': {'nctId': 'NCT03178903', 'acronym': 'StRIDE', 'briefTitle': 'tDCS for Increasing Exercise Adherence in Depressed Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Butler Hospital'}, 'officialTitle': 'tDCS for Increasing Exercise Adherence in Individuals With Elevated Depressive Symptoms', 'orgStudyIdInfo': {'id': '1608-002'}, 'secondaryIdInfos': [{'id': 'R21CA214102', 'link': 'https://reporter.nih.gov/quickSearch/R21CA214102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tDCS and Aerobic Exercise', 'description': 'Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.', 'interventionNames': ['Other: tDCS', 'Behavioral: Aerobic Exercise (AE)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS and Aerobic Exercise', 'description': 'Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.', 'interventionNames': ['Other: Sham tDCS', 'Behavioral: Aerobic Exercise (AE)']}], 'interventions': [{'name': 'tDCS', 'type': 'OTHER', 'description': 'Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.', 'armGroupLabels': ['tDCS and Aerobic Exercise']}, {'name': 'Sham tDCS', 'type': 'OTHER', 'description': 'Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.', 'armGroupLabels': ['Sham tDCS and Aerobic Exercise']}, {'name': 'Aerobic Exercise (AE)', 'type': 'BEHAVIORAL', 'description': 'Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.', 'armGroupLabels': ['Sham tDCS and Aerobic Exercise', 'tDCS and Aerobic Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Butler Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}