fMRI-neuronavigated Repetitive Transcranial Magnetic Stimulation for the Treatment of Major Depression Associated With Traumatic Brain Injury
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Improvement in depressive symptoms
研究概览
简要总结
This pilot study aims to investigate the efficacy of fMRI-targeted repetitive transcranial magnetic stimulation (rTMS) in treatment of major depression associated with traumatic brain injury (TBI). Half of patients will receive active treatment, while the other will receive a sham treatment with the option of receiving open-label active treatment afterwards.
详细描述
rTMS is an FDA-approved treatment for major depressive disorder, but its utility has not yet been investigated for major depression associated with traumatic brain injury.
This will be a prospective double-blind randomized sham-controlled crossover study. Patients in the treatment group will receive 20 sessions of high-frequency rTMS over the left dorsolateral prefrontal cortex (DLPFC) and low-frequency rTMS over the right DLPFC. The DLPFC will be identified as target by using individual subject-level resting state network estimation (Hacker et al, 2013). Patients in the control group will receive 20 sham treatments designed to be visibly indistinguishable from active treatment, and will subsequently have the option to be crossed over to receive active treatment with the aforementioned protocol. A subgroup of patients in each group will receive more detailed diffusion imaging (diffusion tensor and diffusion kurtosis imaging) and resting state fMRI scans before and after the treatment in order to assess for changes in white matter integrity and functional connectivity associated with the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Active rTMS
Subjects will receive a full course of 20 rTMS treatments over 20 consecutive weekdays as described above.
干预措施: Active (Procedure)
Sham/crossover rTMS
Rather than receiving active treatment, subjects will receive sham treatment designed to be indistinguishable from active treatment to the patient. After completion of the sham course, patients will have the option to receive open-label active treatment at no cost.
干预措施: Sham (Procedure)
结局指标
主要结局
Improvement in depressive symptoms
时间窗: Difference between pre-treatment (baseline) and post-treatment (4 weeks)
This will be measured as the mean percentage change in baseline scores on Montgomery-Asberg Depression Rating Scale (MADRS) before treatment and immediately after the 4-week treatment period.
次要结局
- Changes in headache scales(Difference between pre-treatment (baseline) and post-treatment (4 weeks))
- Changes in resting-state fMRI and DTI findings(Difference between pre-treatment (baseline) and post-treatment (4 weeks))
- Response and remission rates in depressive symptoms(Difference between pre-treatment (baseline) and post-treatment (4 weeks))
- Changes in tinnitus score(Difference between pre-treatment (baseline) and post-treatment (4 weeks))
- Changes in NIH Toolbox Cognitive, Emotional, and Quality of Life batteries(Difference between pre-treatment (baseline) and post-treatment (4 weeks))
- Changes in temperament and character(Difference between pre-treatment (baseline) and post-treatment (4 weeks))