Imaging Biomarkers for TMS Treatment of Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Depressive Symptoms at 4 Weeks
研究概览
简要总结
The purpose of this research is to learn more about how rTMS works to reduce the symptoms of depression. This information can be used to improve the effectiveness of the treatment. The study will use functional magnetic resonance imaging (fMRI) to examine changes in brain function after treatment with rTMS. fMRI is a safe and painless technique that allows investigators to observe the brain "at work." The investigators will use fMRI to see what regions of the brain become active when you perform a concentration task and how that activation is changed after rTMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of major depressive disorder
- •Male and female subjects, ages 22-65
- •Have failed at least 1 antidepressant medication at adequate dose and duration
- •On stable antidepressant medication regimen for at least 4 weeks prior to TMS therapy
排除标准
- •Diagnosed with a psychotic, bipolar, obsessive-compulsive or post-traumatic stress disorder
- •Active substance abuse, including alcohol
- •Medical and/or neurological condition that could affect your brain function or risk of seizure, including a stroke, epilepsy, or a closed head injury;
- •No presence of an implanted device like a pacemaker/neurostimulator or metal in the head or body;
- •Pregnant or trying to get pregnant
- •Failed to respond to an adequate course of electroconvulsive therapy (ECT)
- •Previous treatment with TMS
- •Current depressive episode longer than 5 years
研究组 & 干预措施
Active rTMS
20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second fMRI will be completed then 5 additional tapering treatments of rTMS over a 2 week period.
干预措施: repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
Sham rTMS
20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second fMRI scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.
干预措施: repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
结局指标
主要结局
Depressive Symptoms at 4 Weeks
时间窗: 4 weeks after baseline
MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression
次要结局
- Depression Symptoms at 4 Weeks- Secondary(4 weeks after baseline)
研究者
Stephan Taylor
Professor of Psychiatry
University of Michigan