Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale (HDRS21)
研究概览
简要总结
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
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
- •The subject is capable of understanding the study and to sign an informed consent.
- •Subject is between the ages of 18 to 65 years old.
- •Unipolar major depressive disorder
- •Score on the Hamilton Depression Rating Scale (HDRS21) > 22
- •Current MDD episode >3 months
- •Nonresponse with >6 week use of one to six antidepressant in current episode
排除标准
- •History of neurosurgical interventions.
- •Subjects with metal implants or shrapnel in their head, except for dental implants.
- •Skin lesion or inflammation at the region of the stimulating electrodes.
- •Pregnancy or Lactation.
- •Women of reproductive age not using efficient contraceptive method.
- •History of cerebrovascular event.
- •Psychotic or bipolar depression
- •History of schizophrenia, schizoaffective disorder or other non-mood disorder psychosis
- •Current delirium, dementia, amnestic disorder or other cognitive disorders
- •Clinically significant current suicidal intent as assessed by the investigator team.
- •Obsessive-compulsive disorder or post-traumatic stress disorder
- •Alcohol and non-alcohol psychoactive substance abuse or dependence
- •Significant cardiac, medical, or progressive neurological or medical illness
- •An implantable electrical device such as a pacemaker.
研究组 & 干预措施
Neurolief System treatment
Treatment with the Neurolief system will be applied by the subject at his home and/or surrounding daily during a period of six weeks
干预措施: Neurolief system (Device)
结局指标
主要结局
Hamilton Depression Rating Scale (HDRS21)
时间窗: 6 weeks
Change in the total score on the Hamilton Depression Rating Scale (HDRS21) from baseline (visit 1) to week 6 (visit 4).
Incidence of Treatment-Emergent Adverse Events
时间窗: 6 weeks
Safety measures will be recorded and evaluated at every evaluation visit. It will be coded using the Medical Dictionary for Regulatory Activities. Vital signs (blood pressure and pulse) will be assessed and documented at each evaluation visit.
次要结局
未报告次要终点