Efficacy and Safety of MRI Compatible and Long-term LFP Recordable Deep Brain Stimulation in Patients With Treatment-Resistant Depression
试验速览
- 阶段
- 不适用
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in the Hamilton Anxiety Scale
研究概览
简要总结
The habenula (Hb) is an ancient structure, located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. An increasing number of studies indicated that the lateral habeluna (LHb) is overactivity during depressive behaviors in rats, where it could drive the changes in midbrain monoamine neurotransmitter linked to depression. However, the efficiency and mechanism of deep brain stimulation (DBS) of the LHb and/or its major afferent bundle (i.e., stria medullaris thalami) could treat treatment-resistant major depression (TRD) is still unclear. This research will investigate the effectiveness and mechanism of bilateral MRI Compatible and Long-term LFP Recordable DBS to habenula and/or its major afferent bundle for treatment TRD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old;
- •DSM-IV diagnosis of Major depression disorder of psychiatrists;
- •More than 3 year's history of depression and failure to respond to a minimum of three different antidepressant treatments;
- •Failure or intolerance or unwilling of an adequate course of electroconvulsive therapy (ECT) during any episode;
- •HAMD-17≥20;
- •Capacity to provide informed consent (understanding of the study purpose and methods);
排除标准
- •Obvious medical and psychiatric comorbidities;
- •Alcohol or substance abuse/dependence within 12 months;
- •Antisocial personality disorder, dementia, current tic disorder;
- •Subject has a history of 2 or more suicide attempts < 12 months prior to the screening testing;
- •Pregnancy and/or lactation;
- •There are contraindications for DBS surgery and chronic stimulation.
研究组 & 干预措施
Device
MRI compatible and LFP recordable implantable stimulator
干预措施: Bilateral implantation of DBS system to Habeluna (Procedure)
结局指标
主要结局
Change in the Hamilton Anxiety Scale
时间窗: Baseline（preoperative）,3 months, 6 months, 12months
Change in the Hamilton Anxiety Scale after the DBS on
次要结局
未报告次要终点