Remotely Programmed Deep Brain Stimulation of the Bilateral Habenula for Treatment- Resistant Major Depression: An Open Label Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in the Montgomery-Asberg Depression Rating Scale
研究概览
简要总结
The habenula(Hb) is an epithalamic 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 indicates that that overactivity in the lateral habeluna(LHb) is present during depressed states, where it could drive the changes in midbrain activity linked to depression. Deep brain stimulation(DBS) of the major afferent bundle (i.e., stria medullaris thalami) of the LHb can treat treatment-resistant major depression(TRD). There is no clinical case of directly stimulating habeluna for treatment TRD. This research will investigate effectiveness bilateral DBS to habenula for patients with TRD.
Programming is a crucial aspect of DBS which directly influences its therapeutic efficacy. Researchers need to ascertain optimum stimulation parameters to help patients achieve optimal control of clinical symptoms. Remote programming of DBS can markedly improve patient convenience, minimize risk of infection and total treatment time and lead to an overall benefit for doctors and patients alike. This research will also investigate safety and benefit of remote programming of DBS.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old
- •Proficiency in Mandarin language;
- •DSM-IV diagnosis of Majior depression disorder;
- •Current episode duration ≥ 2 years;
- •Failure to respond to a minimum of four different antidepressant treatments;
- •Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode;
- •Capacity to provide informed consent (understanding of the study purpose and methods);
排除标准
- •Schizophrenia or history of psychosis unrelated to MDD;
- •Antisocial personality disorder, dementia, current tic disorder;
- •Past stereotactic neurosurgical intervention;
- •Alcohol or substance abuse/dependence within 6 months;
- •Neurological disease (Abnormal PET-CT, MRI, EEG);
- •Contraindications of MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator;
- •Contraindications of stereotactic intervention, e.g. increased bleeding disposition, cerebrovascular diseases;
- •Serious and unstable organic diseases (e.g. unstable coronal heart disease);
- •HIV positive;
- •Pregnancy and/or lactation;
结局指标
主要结局
Change in the Montgomery-Asberg Depression Rating Scale
时间窗: Baseline (preoperative),Biweekly after onset of the DBS system,3 months,6 months, 9 months, 12 months
Change in the Hamilton Depression Scale
时间窗: Baseline（preoperative）,3 months, 6 months,9 months, 12months
次要结局
- Change in Young Manic Rating Scale(Baseline (preoperative),Biweekly after onset of the DBS system,3 months,6 months, 9 months, 12 months)
- Change in the Hamilton Anxiety Scale(Baseline（preoperative）,3 months, 6 months,9 months, 12 months)
- Change in the Quality of Life Assessment (SF-36)(Baseline（preoperative）,3 months, 6 months,9 months, 12 months)
- Neuropsychological measures(Scores of cogstate battery)(Baseline（preoperative）,6 months,12 months)
- Change in the WHO-BREF(Baseline（preoperative）,3 months,6 months,9 months, 12 months)
- Chang in Pittsburgh Sleep Quality Index(Baseline（preoperative）,3 months,6 months,9 months, 12 months)
研究者
Bomin Sun
Director of the Department of Functional Neurosurgery
Ruijin Hospital