NCT07044973招募中不适用
Dual-Target MR-guided Focused Ultrasound for Parkinson Disease
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Device and Procedure Related Adverse Events
研究概览
简要总结
The objective of this prospective, single-arm, open-label study is to assess the safety and efficacy of the staged, dual-target（VIM+PTT thalamotomy）to treat Patiensts with Parkinson Disease using transcranial magnetic resonance guided focused ultrasound system ExAblate 4000, InSightec Ltd.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 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 informed consent and able to attend all study visits
- •Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site
- •Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor sub-scale in the ON vs OFF medication state
- •Disabling motor clinical features not optimally controlled by an adequate medication 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
- •Predominant disability from one side of the body (i.e unilateral or markedly asymmetric disease) as determined by movement disorders neurologist and neurosurgeon
- •Subjects should be on a stable dose of all PD medications for 30 days prior to study entry
- •Subjects are able to communicate sensations during the Exablate Transcranial procedure.
- •The thalamus must be apparent on MRI such that targeting of the Vim nucleus can be performed indirectly by measurement from a line connecting the anterior and posterior commissures of the brain.
- •Topographic coordinates of the pallidothalamic tract are localizable on Magnetic resonance imaging (MRI) so that it can be targeted by the ExAblate device.
- •Subject should have a Screening motor assessment of ≥ 30 while OFF medications on the MDS-UPDRS
- •Subject has a baseline CRST Part A score of 2 or above for postural or intention tremor severity in the upper extremity for the contralateral tremor side while on stable medication
- •Subject has a baseline CRST Part C score of 2 or above in any one of the items (speaking, eating, drinking, hygiene, dressing, writing, working, and social activities).
排除标准
- •Hoehn and Yahr stage in the ON medication state of 2 or lower
- •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 presence of significant cognitive impairment as determined with a score ≤ 24 on the Mini Mental Status Examination (MMSE)
- •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 with unstable cardiac status including:
- •Unstable angina pectoris on medication
- •Subjects with documented myocardial infarction within six months of protocol entry
- •Significant congestive heart failure defined with ejection fraction < 40
- •Subjects with unstable ventricular arrhythmias
- •Subjects with atrial arrhythmias that are not rate-controlled
- •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 <30 mL/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
- •Subjects who weigh 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 brain tumors
- •Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment
- •Are participating or have participated in another clinical trial in the last 30 days
- •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 with remarkable atrophy and poor healing capacity of the scalp (> 30% of the skull area traversed by the sonication pathway) will be excluded from this study
- •Subjects who have an overall Skull Density Ration lower than 0.30 as calculated from the screening CT
研究组 & 干预措施
ExAblate Treatment
Experimental
Participants will undergo a VIM and PTT thalamotomy using MRgFUS
干预措施: Transcranial focused ultrasound thalamotomy (Procedure)
结局指标
主要结局
Number of Device and Procedure Related Adverse Events
时间窗: 2 Years post treatment
The cumulative sum of adverse events was followed through Year 2 of the study
次要结局
- Clinical Rating Scale for Tremor (CRST)(Baseline,1 Month, 3 Months, 6 Months, 12 Months, 2 Years post treatment)
- MDS-UPDRS (Movement Disorder Scale-Unified Parkinson's Disease Rating Scale), Part III(Baseline,1 Month, 3 Months, 6 Months, 12 Months, 2 Years post treatment)
- Quality of life assessment with PDQ-39(Baseline,1 Month, 3 Months, 6 Months, 12 Months, 2 Years post treatment)
研究者
Longsheng Pan
Professor
Chinese PLA General Hospital
研究点 (1)
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