Longitudinal, Prospective Study to Examine the Brain-based Biomarkers of Response to Transcranial Magnetic Stimulation Treatment in Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- TMS-EEG
研究概览
简要总结
The overarching goal of this research program is to elucidate causal and directional neural network- level abnormalities in depression, and how they are modulated by an individually-tailored, circuit-directed intervention. By using concurrent TMS and EEG, the investigators can overcome a major limitation of EEG - the inability to demonstrate causality. Here, we plan to recruit patients with medication-resistant depression undergoing rTMS treatment. At multiple time points, we will perform TMS-EEG to investigate the excitability and connectivity profiles of brain networks and how they are modulated during treatment. This study aims to provide objective brain network measures that can predict and track clinical response to TMS treatment. Findings from this study will be utilized to develop a novel, personalized treatment protocol based on individual brain networks.
详细描述
Goals of the study are as follows:
- To evaluate the ability to predict and track brain network changes during TMS treatment for medication-resistant depression.
- To develop quantitative tools that measure the connectivity and excitability of the brain using resting and single pulse TMS-EEG.
- To determine the feasibility of recording EEG biomarkers in the clinic without disrupting clinical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, ages 18 to 60
- •Medication-resistant depression as assessed by psychiatrist
- •Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
- •Has failed >1 previous adequate antidepressant medication trials
- •Right-handed
- •No current or history of neurological disorders
- •No seizure disorder or risk of seizures
- •No use of PRN medication within 48 hours of the scheduled study appointment
排除标准
- •Any unstable medical condition, any significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc
- •Current electroconvulsive therapy (ECT) or prior treatment failure with ECT
- •Currently pregnant or breastfeeding
结局指标
主要结局
TMS-EEG
时间窗: Up to 3 months
From pre- to post-treatment, improvement will be based on enhanced excitability and connectivity
次要结局
未报告次要终点
研究者
Corey Keller
Assistant Professor of Psychiatry and Behavioral Sciences
Stanford University