Actively Recruiting
VIM+PTT MRgFUS for PD
Led by Chinese PLA General Hospital · Updated on 2025-07-01
20
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VIM+PTT MRgFUS for PD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women age 30 years or older
- Able and willing to give informed consent and attend all study visits
- Diagnosed with idiopathic Parkinson Disease by UK Brain Bank Criteria confirmed by a movement disorder neurologist
- Responsive to Levodopa with at least 30% improvement in motor symptoms
- Disabling motor symptoms not well controlled by adequate medication
- Predominant disability on one side of the body as determined by specialists
- On a stable dose of Parkinson Disease medications for at least 30 days before study entry
- Able to communicate sensations during the ExAblate transcranial procedure
- Thalamus and pallidothalamic tract visible and localizable on MRI for targeting
- Screening motor assessment score of 30 or higher off medications on MDS-UPDRS
- Baseline tremor severity and functional impairment scores meeting minimum thresholds
You will not qualify if you...
- Hoehn and Yahr stage 2 or lower while on medication
- Severe dyskinesia with high scores on MDS-UPDRS questions 4.1 and 4.2
- Other central neurodegenerative diseases suspected (e.g., multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, Alzheimer's disease)
- Parkinsonian symptoms suspected to be due to neuroleptic medications
- Previous deep brain stimulation or basal ganglia ablation
- Significant cognitive impairment (MoCA ≤ 21 or MMSE ≤ 24)
- Unstable psychiatric disease or significant depression as determined by assessments
- Legal incapacity or limited legal capacity
- Unstable cardiac conditions including recent myocardial infarction, heart failure with ejection fraction <40%, uncontrolled arrhythmias
- Severe hypertension (diastolic BP > 100 on medication)
- Medical conditions causing abnormal bleeding or coagulopathy
- Recent use of anticoagulant or antiplatelet drugs before the procedure
- Risk factors for bleeding such as low platelet count or abnormal coagulation tests
- Severely impaired kidney function or dialysis
- Standard contraindications for MRI such as incompatible implanted devices or size limits
- Significant claustrophobia not manageable with mild medication
- Weight exceeding MRI table limits or inability to fit in scanner
- Inability to tolerate prolonged stationary supine position during treatment
- History of intracranial hemorrhage, multiple strokes, or recent stroke within 6 months
- Seizures within the past year
- Brain tumors, intracranial aneurysms, or arteriovenous malformations requiring treatment
- Participation in another clinical trial within the last 30 days
- Any illness precluding study participation as judged by the investigator
- Inability to communicate with study staff
- Pregnancy or lactation
- Significant scalp atrophy or poor healing over skull area targeted by ultrasound
- Skull Density Ratio lower than 0.30 on screening CT scan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
X
Xin He, MD;Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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