ISRCTN13759640终止未知
Prospective, feasibility trial for high-frequency deep brain stimulation in the treatment of movement disorders
evro Corp0 个研究点目标入组 3 人开始时间: 2019年1月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 3
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
- 性别
- All
入选标准
- •To participate in the study, subjects must meet all of the following inclusion criteria:
- •1. Have been clinically diagnosed with either bilateral idiopathic Parkinson’s disease or unilateral or bilateral essential tremor, which has been refractory to conservative therapy for a minimum of 3 months and completed diagnostic work-up
- •2. Be 18 years of age or older at the time of enrollment
- •3. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- •4. Be capable of subjective evaluation; patient must be able to describe and rate his/her disease state progression through the UPDRS
- •5. Be willing and capable of giving informed consent
- •6. Be willing and able to comply with study-related requirements and procedures and attend all scheduled visits
- •7. Have adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator
排除标准
- •To participate in this study, a subject must not meet any of the following exclusion criteria.
- •1. Have a medical condition, not intended to be treated with DBS that could interfere with study procedures, accurate UPDRS or FTD reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
- •2. Have a current diagnosis of a focal brain tumor in a relevant DBS target region or prominent generalized cortical atrophy, as determined by the investigator
- •3. Have a past medical history significant for seizures, as determined by the investigator
- •4. Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the investigator
- •5. Have a condition that would significantly increase perioperative risk including severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, symptomatic uncontrolled diabetes mellitus that presents excess risk for performing the procedure as determined clinically by the investigator
- •6. Any previous history of surgery of ipsilateral basal ganglia surgery (radio frequency or ultrasound lesion or prior DBS implant)
- •7. Any past medical history suggesting secondary or atypical parkinsonian symptoms including previous cerebrovascular accident, neurotoxin exposure, neuroleptic toxicity, tumor, encephalitis, abnormal iron deposits, or neurologic signs of cerebellar or upper motor neuron involvement or supranuclear gaze palsy
- •8. Be benefiting from an interventional procedure and/or surgery to treat their movement disorder (Subjects should be enrolled at least 30 days from last benefit)
- •9. Have an existing drug pump and/or another active implantable device such as a pacemaker
- •10. Have a condition currently requiring or likely to require the use of diathermy, Transcranial Magnetic Stimulation (TMS) or MRI imaging that is inconsistent with Senza II system guideline in the US manual
- •11. Have either a metastatic malignant neoplasm or untreated local malignant neoplasm
- •12. Have a life expectancy of less than one year
- •13. Have a local infection at the anticipated surgical entry site or an active systemic infection
- •14. Be pregnant or plan to become pregnant during the study. Women of childbearing potential who are sexually active must use a reliable form of birth control, or be surgically sterile, or be at least 2 years post-menopausal
- •15. Have a significant untreated addiction to dependency producing medications or have been a substance abuser (including opioids, benzodiazepines, alcohol and illicit drugs) within 6 months of enrollment
- •16. Have a metallic aneurysm clip that could interfere with device functioning
- •17. Have significant cognitive impairment or dementia that would interfere with study compliance or comprehension
- •18. Have untreated clinically significant depression as evidenced by a self-report score on the Beck Depression Inventory (BDI) II > 20. Patients presenting with depression may also be ruled out by clinical judgement of the investigator
- •19. Have evidence of acute psychosis or delirium as determined by the investigator
- •20. Be concomitantly participating in another clinical study
研究者
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