Cognitive Impairment
Conditions
Keywords
Depression, Transcranial Magnetic Stimulation (TMS)
Brief summary
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
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.
Interventions
BEHAVIORALTMS and Lumosity®cognitive retraining
The Lumosity® training includes exercises for speed, memory, attention, flexibility, and problem solving. Subjects will complete this battery while receiving TMS treatment.
BEHAVIORALTMS and non cognitive computer games
Subjects will play computer games while receiving TMS treatment.
Sponsors
Lumos Labs, Inc.
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The University of Pennsylvania Computerized Neuropsychological Testing Battery (Penn CNP) | Change from baseline at six weeks | Administers computerized neuropsychological tests for research studies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Lumosity® Brain Performance Test (BPT) | Change from baseline at six weeks | Online neuropsychological battery of assessments measuring training-related changes in Cognitive Performance |
| Inventory of Depressive Symptoms- Self Report | Change from baseline at six weeks | Patient rating of depressive symptom severity |
| Hamilton Depression Rating Scale 17 item | Change from baseline at six weeks | Clinician Rating of Depressive Symptoms |
Countries
United States
Outcome results
None listed