Dorsolateral Versus Medial Prefrontal TMS for Depression
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale
研究概览
简要总结
This study is aimed to help us learn about the effects of Transcranial Magnetic Stimulation at the forehead versus the left side of the head for treatment of Treatment Resistant Depression.
详细描述
While transcranial magnetic stimulation (TMS) to the left dorsolateral prefrontal cortex (DLPFC) is an FDA approved treatment for depression, a growing and converging database suggests the medial prefrontal cortex (MPFC) may be even more critical to the neurobiology of depression and antidepressant treatment response. This study will compare the efficacy of high frequency transcranial madntic stimulation on these two sections of the brain.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-70 years old
- •inadequate response to one current antidepressant medication
- •currently depressed
排除标准
- •psychiatric comorbidities
研究组 & 干预措施
Intervention Arm
Participants will receive TMS. They will be randomized to either the left dorsolateral prefrontal cortex or the medial prefrontal cortex.
干预措施: TMS (Device)
Treatment Arm
After the experimental arm, if a patient was randomized to the medial prefrontal cortex during the experimental arm and it did not work for them, they have the option of returning for a session of TMS to the FDA-approved dorsolateral prefrontal cortex.
If they were assigned to the dorsolateral prefrontal cortex, they are not eligible to return for another set of treatment.
干预措施: TMS (Device)
结局指标
主要结局
Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale
时间窗: Change from baseline Hamilton-17 score to follow-up visit at 1 week after final TMS intervention.
Depressive symptoms will be measured by the 17-item Hamilton Depression Rating Scale.
次要结局
未报告次要终点
研究者
Paul Holtzheimer
Director of Mood Disorder Services
White River Junction Veterans Affairs Medical Center