JPRN-jRCTs032180407暂停1 期
Feasibility Study to Evaluate the Safety and Effectiveness of Bilateral Magnetic Resonance-guided Focused Ultrasound (MRgFUS) Ablation of the Pallido-Thalamic Tract for the Treatment of Advanced Parkinson's Disease - PD005
Ikezawa Jun0 个研究点目标入组 10 人开始时间: 2019年3月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 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
- Interventional
入排标准
- 年龄范围
- >= 30age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Men and women age 30 years and older
- •2.Patients who are able and willing to give consent and able to attend all study visits
- •3.A diagnosis of idiopathic Parkinson's Disease by UK Brain Bank Criteria as confirmed from clinical history and examination by a neurologist specializing Parkinson's disease by the presence of tremor at rest, bradykinesia and rigidity
- •4.Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
- •5.Symptoms have been resistant to optimal pharmacologic treatment including L-dopa and other antiparkinsonian drugs for at least 1 year.
- •6.Subjects on stable (i.e., no change in medication drug or dosage for 3 months) antidepressant medications for at least 3 months may be enrolled into this study.
- •7.Disabling motor complications of PD on optimum medical treatment (dyskinesia etc.) characterized by at least one of the two most clinically relevant symptoms (e.g. tremor at rest or dyskinesia - must have a score of >= 3 on the MDS-UPDRS, questions 3.17a-e or 4.2).
- •8.Strongly diminished quality of life.
- •9.The pallido-thalamic region can be targeted by the ExAblate device.
- •10.Able to communicate sensations during the ExAblate MRgFUS treatment.
- •11.Patients are on stable doses of all PD medications for 30 days prior to study entry.
- •12.Inclusion and exclusion criteria have been agreed upon by two members of the medical team.
排除标准
- •1.Patients with unstable cardiac status including:
- •a)Unstable angina pectoris on medication
- •b)Patients with documented myocardial infarction within six months of protocol entry
- •c)Congestive heart failure requiring medication (other than diuretic)
- •d)Patients on anti-arrhythmic drugs
- •2.Criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within a 12 month period:
- •a)Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household).
- •b)Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)
- •c)Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)
- •d)Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).
- •3.Severe hypertension (diastolic BP > 100 on medication)
- •4.Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- •5.Severely impaired renal function (estimated glomerular filtration rate < 45ml/min/1.73 m2) or receiving dialysis
- •6.History of abnormal bleeding and/or coagulopathy
- •7.Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
- •8.Active or suspected acute or chronic uncontrolled infection
- •9.History of intracranial hemorrhage
- •10.Cerebrovascular disease (multiple CVA or CVA within 6 months)
- •11.Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.)
- •12.Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema)
- •13.Are participating or have participated in another clinical trial in the last 30 days
- •14.Patients unable to communicate with the investigator and staff.
- •15.Presence of any other neurodegenerative disease and/or dementia
- •16.Presence of significant cognitive impairment as determined with a score <= 24 on the Mini Mental Status Examination (MMSE)
- •17.History of immune-compromise, including patient who is HIV positive
- •18.Known life-threatening systemic disease
- •19.Patients with a history of seizures within the past year
- •20.Patients with current or prior history of psychiatric illness will be excluded, (e.g., presence or history of psychosis will be excluded; patients with mood disorders including unstable or uncontrolled depression will be excluded.) For the purpose of this study, we consider a significant mood disorder to include any patient who has:
- •a.been under the care of a psychiatrist for over 3 months for non-pharmaceutical therapy
- •b.has participated in cognitive-behavioral therapy
- •c.been hospitalized for the treatment of a psychiatric illness
- •d.received transcranial magnetic stimulation
- •e.received electroconvulsive therapy
- •21.Patients with risk factors for intraoperative or
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