Mental Activity During Transcranial Magnetic Stimulation (TMS) Therapy for Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- The University of Pennsylvania Computerized Neuropsychological Testing Battery (Penn CNP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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.
排除标准
- 未提供
研究组 & 干预措施
TMS and Lumosity® cognitive retraining
Group will receive TMS and will concurrently engage in cognitive retraining exercises comprised of the Lumosity® battery.
干预措施: TMS and Lumosity®cognitive retraining (Behavioral)
TMS and non cognitive computer games
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
干预措施: TMS and non cognitive computer games (Behavioral)
结局指标
主要结局
The University of Pennsylvania Computerized Neuropsychological Testing Battery (Penn CNP)
时间窗: Change from baseline at six weeks
Administers computerized neuropsychological tests for research studies
次要结局
- Hamilton Depression Rating Scale 17 item(Change from baseline at six weeks)
- The Lumosity® Brain Performance Test (BPT)(Change from baseline at six weeks)
- Inventory of Depressive Symptoms- Self Report(Change from baseline at six weeks)
研究者
Peter Rosenquist
Professor
Augusta University