NL-OMON39039已完成不适用
Intra-operative evaluation of efficacy and safety of a new lead for steering Deep Brain Stimulation. First Acute-in-Man Evaluation of Steering Brain Stimulation (FAME ) - FAME
Sapiens Steering Brain Stimulation BV0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Diagnosis of idiopathic Parkinson*s disease
- •Clinical indication for STN DBS with MER.
- •Age > 18 years
- •Subject is a male or non-pregnant female
- •Ability to comply with the study assignments.
- •Ability to give informed consent.
排除标准
- •Parkinson*s disease graded according to Hoehn and Yahr stage 5
- •Score on MATTIS dementia rating scale <120
- •Psychiatric contraindications to STN DBS
- •General contraindications for stereotactic surgery and general anaesthesia (e.g. severe hypertension, blood coagulation disorder)
- •Subject has 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 or history of hemorrhagic stroke, that in the view of the neurosurgeon or neurologist would place the subject at an increased risk for intra-operative or postoperative bleeding.
- •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.
研究者
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