Mental Activity During (TMS) Therapy for Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mental Activity During Transcranial Magnetic Stimulation (TMS) Therapy for Depression

Conditions
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Cognitive Impairment

Intervention / Treatment
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* Behavioral: TMS and Lumosity®cognitive retraining
* Behavioral: TMS and non cognitive computer games


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Subject has a diagnosis of depression Subject has been approved and scheduled to receive TMS at Augusta University Subject does not have a major neurocognitive impairment or an alcohol or substance abuse disorder, and can see images on a computer monitor. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMS and Lumosity® cognitive retraining<br>Group will receive TMS and will concurrently engage in cognitive retraining exercises comprised of the Lumosity® battery. | Behavioral: TMS and Lumosity®cognitive retraining<br>* The Lumosity® training includes exercises for speed, memory, attention, flexibility, and problem solving. Subjects will complete this battery while receiving TMS treatment.<br>|
| Active Comparator: TMS and non cognitive computer games<br>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 | Behavioral: TMS and non cognitive computer games<br>* Subjects will play computer games while receiving TMS treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Transcranial Magnetic Stimulation (TMS)