Actively Recruiting
MR-guided Focused Ultrasound Plus GCase
Led by InSightec · Updated on 2026-01-23
14
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to establish safety and feasibility of intracerebral delivery of GCase via MRgFUS. This technique may offer potential benefits given the exposure of the putamen to GCase in animal models has been shown to be efficacious in improving Parkinson's disease pathology and phenotype.
CONDITIONS
Official Title
MR-guided Focused Ultrasound Plus GCase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women between age 35 and 80 years, inclusive
- Able and willing to give informed consent
- Diagnosis of Parkinson's disease meeting MDS Clinical Diagnostic Criteria
- At least 2 years since initial diagnosis
- Hoehn and Yahr Stage 1-3 while on Parkinson's medications
- Positive dopaminergic deficit confirmed by DAT SPECT scan
- Stable Parkinson's medication regimen for at least 90 days prior
- American Society of Anesthesiologists (ASA) score between 1 and 3
- Have at least one GBA mutation if in the GBA Parkinson's disease group, or two wild-type GBA alleles if in the idiopathic group
You will not qualify if you...
- Positive pregnancy test for pre-menopausal women
- Contraindication to DEFINITY ultrasound contrast agent or perflutren (such as hypersensitivity or known cardiac shunts)
- Contraindication to MRI or gadolinium-DTPA (such as incompatible devices or hypersensitivity)
- Insulin-dependent diabetes mellitus that is poorly controlled or deemed unsuitable by the investigator
- Severely impaired kidney function with eGFR less than 30 mL/min/1.73m2 or on dialysis
- Currently enrolled in another clinical therapeutic trial
- Receiving bevacizumab (Avastin) therapy
- Evidence of cranial or systemic infection
- Cerebral or systemic vasculopathy
- History of cerebral infarction within the past 12 months or transient ischemic attack within the past month
- Known hypersensitivity to GCase enzyme therapy
- Presence of parkinsonism plus symptoms or secondary parkinsonism
- Previous neurosurgical procedure for Parkinson's disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sunybrook Research Institute
Toronto, Ontario, Canada
Actively Recruiting
Research Team
A
Alyssa Voelker-Christy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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