Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-02-26 @ 12:43 AM
Study NCT ID:
NCT03701932
Status:
COMPLETED
Last Update Posted:
2020-08-28
First Post:
2018-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mental Activity During (TMS) Therapy for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-27', 'studyFirstSubmitDate': '2018-03-26', 'studyFirstSubmitQcDate': '2018-10-08', 'lastUpdatePostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The University of Pennsylvania Computerized Neuropsychological Testing Battery (Penn CNP)', 'timeFrame': 'Change from baseline at six weeks', 'description': 'Administers computerized neuropsychological tests for research studies'}], 'secondaryOutcomes': [{'measure': 'The Lumosity® Brain Performance Test (BPT)', 'timeFrame': 'Change from baseline at six weeks', 'description': 'Online neuropsychological battery of assessments measuring training-related changes in Cognitive Performance'}, {'measure': 'Inventory of Depressive Symptoms- Self Report', 'timeFrame': 'Change from baseline at six weeks', 'description': 'Patient rating of depressive symptom severity'}, {'measure': 'Hamilton Depression Rating Scale 17 item', 'timeFrame': 'Change from baseline at six weeks', 'description': 'Clinician Rating of Depressive Symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression, Transcranial Magnetic Stimulation (TMS)'], 'conditions': ['Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the effects of different types of mental activity performed while receiving transcranial magnetic stimulation (TMS) for the treatment of major depressive disorder. Our primary aim for this study is to assess the feasibility of combining TMS and computer based cognitive exercise in patients with major depressive disorder who may also have some degree of cognitive dysfunction, and to formally measure changes in mood and cognition over the course of the study.', 'detailedDescription': 'Patients will receive TMS treatment daily for 6 weeks as part of their standard care. They will complete clinical assessments and participate in cognitive retraining through completion of 15 hours of Lumosity gaming cognitive exercises while simultaneously receiving active TMS stimulation. Those participants in the control group will complete 15 hours of computer gaming activity during the administration of active stimulation. Computer games in the control group exercises are elected by the patient from a library of intellectually and motivationally engaging games drawn from several gaming software compilations that includes Play 101 Games and Hoyle Puzzle and Board Games.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Subject has a diagnosis of depression\n\n * Subject has been approved and scheduled to receive TMS at Augusta University\n * Subject does not have a major neurocognitive impairment or an alcohol or substance abuse disorder, and can see images on a computer monitor.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03701932', 'briefTitle': 'Mental Activity During (TMS) Therapy for Depression', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'Mental Activity During Transcranial Magnetic Stimulation (TMS) Therapy for Depression', 'orgStudyIdInfo': {'id': '663245'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TMS and Lumosity® cognitive retraining', 'description': 'Group will receive TMS and will concurrently engage in cognitive retraining exercises comprised of the Lumosity® battery.', 'interventionNames': ['Behavioral: TMS and Lumosity®cognitive retraining']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TMS and non cognitive computer games', 'description': 'Group will receive TMS while concurrently engaging in selected computer games from several gaming software that includes Play 101 Games and Hoyle Puzzle and Board Games®. They will also be allowed to spend time on gaming activities of their choice in order to keep them engaged', 'interventionNames': ['Behavioral: TMS and non cognitive computer games']}], 'interventions': [{'name': 'TMS and Lumosity®cognitive retraining', 'type': 'BEHAVIORAL', 'description': 'The Lumosity® training includes exercises for speed, memory, attention, flexibility, and problem solving. Subjects will complete this battery while receiving TMS treatment.', 'armGroupLabels': ['TMS and Lumosity® cognitive retraining']}, {'name': 'TMS and non cognitive computer games', 'type': 'BEHAVIORAL', 'description': 'Subjects will play computer games while receiving TMS treatment.', 'armGroupLabels': ['TMS and non cognitive computer games']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'overallOfficials': [{'name': 'Peter B Rosenquist, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Augusta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lumos Labs, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Peter Rosenquist', 'investigatorAffiliation': 'Augusta University'}}}}