NCT01098565终止1 期
Deep Brain Stimulation Effects: Human Proof-of-Concept Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- The HFR0001 device can elicit distinct intra-operative responses in subject symptoms.
研究概览
简要总结
The purpose of this study is to provide proof-of-concept that the test product can perform as intended in an intra-operative setting and the responses to the test product are perceivable in a person. The study will also compare results of the test product to the commercially-available product.
Hypothesis: the test product will elicit successful test results in over 90% of test product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is indicated for Activa® DBS implant for the treatment of Parkinson's disease and scheduled for surgery at the study site.
- •Subject is willing to sign the informed consent to participate in the study.
- •Subject is 18 years of age or older.
- •Subject is a male or non-pregnant female.
- •Subject has no factors that would put the subject at an additional risk for intra-operative or postoperative bleeding. This includes underlying disorders of the coagulation cascade (eg, hemophilia), disorders that affect platelet count or function (eg, Von Willebrand's disease), as well as administration of any anti-platelet or anti-coagulant medication in the 7 days prior to surgery, or any history of anticoagulant or aspirin use, that in the view of the neurosurgeon or neurologist would place the subject at an increased risk for intra-operative or postoperative bleeding.
排除标准
- •Subject is indicated for DBS for treating a disorder other than Parkinson's disease.
- •Subject has any medical contraindications to undergoing DBS surgery, (eg, infection, coagulopathy, or significant cardiac or other medical risk factors for surgery).
- •Subject has a history of hemorrhagic stroke.
- •Subject has a history of a neurosurgical ablation procedure.
- •Subject is currently enrolled in or plans to enroll in any concurrent study that may confound the results of this study, as determined by the investigator or Medtronic.
- •Subject has a diagnosis of acute myocardial infarction or cardiac arrest less than or equal to 6 months prior to the screening testing.
- •Subject has a history of a seizure disorder
- •Subject requires short surgery time due to general health issues, as determined by the investigator.
- •Subject is a woman who is pregnant or planning to become pregnant, or a woman of child-bearing potential, who is not using a medically-acceptable method of birth control. Women of child-bearing potential must undergo a pregnancy test, with a clear negative result, no more than 7 days prior to the investigational procedure visit.
结局指标
主要结局
The HFR0001 device can elicit distinct intra-operative responses in subject symptoms.
时间窗: 9 months
Responses include testing parameters and symptom effects
次要结局
- Adverse events that occur with the acute implantation and intra-operative testing of the study device.(9 months.)
研究者
研究点 (2)
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