Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Changes in Functional Connectivity of Key Nodes
研究概览
简要总结
This neuroimaging study is a clinical trial investigating the effectiveness of intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) in reducing suicide risk in patients with major depressive episode (MDE) or borderline personality disorder (BPD).
详细描述
This neuroimaging study aims to determine the effectiveness of iTBS-TMS to the IPL in reducing suicide risk in patients with MDE or BPD. This study also aims to identify the structural and functional circuit properties that characterized the suicidal brain and the signatures that explain the clinical severity of suicidal risk. Moreover, this study aims to determine biological and dimensional predictors of anti-suicidal response to iTBS-TMS and its mechanism of action.
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
- Triple (Participant, 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
- •18-65 years of age
- •Diagnosed with BPD or MDE
- •Chief complaint of suicidal thoughts and behaviors
排除标准
- •Neurological conditions with known structural brain lesion
- •Prior neurosurgical procedure
- •Metal in the body that is ferromagnetic or metal injury to the eyes
- •Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt
- •Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis)
- •Current alcohol dependence or active symptoms of non-alcohol psychoactive substance use withdrawal, as indicated by self-report
- •Inability to meet the safety criteria for MRI scanning according to the protocols of the MGH Department of Radiology
- •Current pregnancy
研究组 & 干预措施
MDE and Active iTBS-TMS
This group will consist of patients diagnosed with MDE that are receiving active iTBS-TMS.
干预措施: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active) (Device)
BPD and Active iTBS-TMS
This group will consist of patients diagnosed with BPD that are receiving active iTBS-TMS.
干预措施: Intermittent Theta Burst Transcranial Magnetic Stimulation (Active) (Device)
MDE and Sham iTBS-TMS
This group will consist of patients diagnosed with MDE that are receiving sham iTBS-TMS.
干预措施: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham) (Device)
BPD and Sham iTBS-TMS
This group will consist of patients diagnosed with BPD that are receiving sham iTBS-TMS.
干预措施: Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham) (Device)
结局指标
主要结局
Changes in Functional Connectivity of Key Nodes
时间窗: Through Treatment Completion, Average of 3 Days
Measured using Magnetic Resonance Imaging
次要结局
未报告次要终点
研究者
Joan A Camprodon, MD MPH PhD
Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation
Massachusetts General Hospital