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| Name | Class |
|---|---|
| Lumos Labs, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS and Lumosity® cognitive retraining | Experimental | Group will receive TMS and will concurrently engage in cognitive retraining exercises comprised of the Lumosity® battery. |
|
| TMS and non cognitive computer games | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS and Lumosity®cognitive retraining | Behavioral | The Lumosity® training includes exercises for speed, memory, attention, flexibility, and problem solving. Subjects will complete this battery while receiving TMS treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The University of Pennsylvania Computerized Neuropsychological Testing Battery (Penn CNP) | Administers computerized neuropsychological tests for research studies | Change from baseline at six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Lumosity® Brain Performance Test (BPT) | Online neuropsychological battery of assessments measuring training-related changes in Cognitive Performance | Change from baseline at six weeks |
| Inventory of Depressive Symptoms- Self Report |
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Inclusion Criteria:
• Subject has a diagnosis of depression
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Peter B Rosenquist, MD | Augusta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusta University | Augusta | Georgia | 30912 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| TMS and non cognitive computer games | Behavioral | Subjects will play computer games while receiving TMS treatment. |
|
Patient rating of depressive symptom severity
| Change from baseline at six weeks |
| Hamilton Depression Rating Scale 17 item | Clinician Rating of Depressive Symptoms | Change from baseline at six weeks |
| D001519 |
| Behavior |