NCT03454425已完成不适用
A Prospective, Randomized, Sham Controlled Study to Evaluate the Safety and Efficacy of ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- InSightec
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Efficacy - MDS-UPDRS
研究概览
简要总结
The objective of this study is to test the efficacy and safety of unilateral subthalamotomy performed using the ExAblate System for the treatment of Parkinson's disease (PD) motor features.
详细描述
A Prospective, Randomized, Sham Controlled Study to Evaluate the Safety and Efficacy of ExAblate Subthalomotomy for the treatment of Parkinson's disease motor features.
The objective of this prospective, randomized, double-blind (to subjects, examining neurologists and external video-based examination by Movement Disorders neurologist), two-arm study (ExAblate treated arm Vs ExAblate Sham treated control arm) is to confirm the efficacy of ExAblate Model 4000 Type 1 System for the treatment of Parkinson's disease (PD) motor features and to further demonstrate safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 30 years or older
- •Subjects who are able and willing to give consent and able to attend all study visits.
- •Subjects with a diagnosis of PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
- •Predominant motor features/disability from one side of the body (i.e asymmetry index > 1.5) as determined by a movement disorders neurologist.
- •Motor clinical features non-optimally controlled by an adequate medical treatment prescription. An adequate medication prescription is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated.
- •No major changes in pharmacological regime for PD should be done for the 30 days prior to procedure.
- •Topographic coordinates of the subthalamic nucleus are localizable on MRI so that it can be targeted by the ExAblate device.
- •Able to communicate sensations during the ExAblate MRgFUS treatment Inclusion and
排除标准
- •have been agreed upon by two members of the medical team
- •Exclusion Criteria:
- •Hoehn and Yahr stage in the ON medication state of 2.5 or greater
- •Presence of severe dyskinesia as noted by a score of 3 or 4 on questions 4.1 and 4.2 of the MDS-UPDRS.
- •Presence of other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease.
- •Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
- •Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
- •Presence of significant cognitive impairment defined as score ≤ 21 on the Montreal Cognitive Assessment (MoCA) or Mattis Dementia Rating Scale of 120 or lower.
- •Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation. Subjects with stable, chronic anxiety or depressive disorders may be included provided their medications have been stable for at least 60 days prior to study entry and if deemed appropriately managed by the site neuropsychologist
- •Subjects with significant depression as determined following a comprehensive assessment by a neuropsychologist. Significant depression is being defined quantitatively as a score of greater than 14 on the Beck Depression Inventory.
- •Legal incapacity or limited legal capacity as determined by the neuropsychologist
- •Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one
- •Subjects with unstable cardiac status including
- •Severe hypertension (diastolic BP > 100 on medication).
- •History of or current medical condition resulting in abnormal bleeding and/or coagulopathy.
- •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
- •Subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter, a documented clinical coagulopathy, or INR coagulation studies exceeding the institution's laboratory standard
- •Patient with severely impaired renal function with estimated glomerular filtration rate <30mL/min/1.73m2 (or per local standards should that be more restrictive) and/or who is on dialysis;
- •Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- •Significant claustrophobia that cannot be managed with mild medication.
- •Subject who weight more than the upper weight limit of the MR table and who cannot fit into the MR scanner
- •Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
- •History of intracranial hemorrhage
- •History of multiple strokes, or a stroke within past 6 months
- •Subjects with a history of seizures within the past year
- •Subjects with malignant brain tumors
- •Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment.
- •Any illness that in the investigator's opinion preclude participation in this study.
- •Subjects unable to communicate with the investigator and staff.
- •Pregnancy or lactation.
- •Subjects who have an Overall Skull Density Ratio lower than 0.35 as calculated from the screening CT.
结局指标
主要结局
Efficacy - MDS-UPDRS
时间窗: Baseline to 4 months post treatment
between-group differences in the mean change (from baseline to 4 months) in the motor MDS-UPDRS score for the side contralateral to subthalamotomy (in the treated group) as compared with mean change in the MDS-UPDRS score for the side contralateral to the alleged subthalamotomy (in the sham-procedure group) in the off-medication condition
Safety - Adverse Events
时间窗: Baseline to 4 Months post treatment
To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate subthalamotomy for the treatment of PD motor features.
次要结局
- MDS-UPDRS III Blinded assessor(Baseline to Month 4 post treatment)
- MDS-UPDRS III OFF-medication(Baseline to Month 4 post treatment)
- MDS-UPDRS II(Baseline to Month 4 post treatment)
- MDS-UPDRS III ON-medication(Baseline to Month 4 post treatment)
- PDG39(Baseline to Month 12 post treatment)
- MDS-UPDRS III(Baseline to Month 4 post treatment)
- GIC(Baseline to Month 4 post treatment)
- MDS-UPDRS III- Contralateral ON-medication(Baseline to Month 4 post treatment)
- MDS-UPDRS IV(Baseline to Month 4 post treatment)
- Levodopa(Baseline to Month 12 post treatment)
- MDS-UPDRS(Baseline to Month 12 post treatment)
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
Pilot Study Evaluating Safety of Unilateral Gamma Knife Subthalamotomy for Parkinson's DiseaseParkinsons DiseaseNCT02249559NYU Langone Health4
撤回
不适用
An Open-label Clinical Trial to Compare the Safety and Effectiveness of Adaptive Versus Conventional Deep Brain StimulationParkinson DiseaseNCT05262348Newronika
已完成
不适用
ExAblate Transcranial MRgFUS of the Subthalamic Nucleus for Treatment of Parkinson's DiseaseParkinson's DiseaseNCT02246374InSightec7
已完成
不适用
Subthalamotomy by ExAblate Transcranial System to Treat Motor Features of Parkinson's DiseaseParkinson's DiseaseNCT02912871Fundación de investigación HM10
进行中（未招募）
不适用
Bilateral Treatment of Medication Refractory Essential TremorEssential TremorNCT04112381InSightec51