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Clinical Trials in Canada / NCT05565443
Recruiting Not applicable

MR-guided Focused Ultrasound Plus GCase

NCT05565443 · tracked via the Priya Life Science Canada tracker
Sponsor
Phase
Not applicable
Started
2022-11-30
Last updated
2026-01-23

Condition(s) studied

Parkinsons Disease

Investigational drug(s) / intervention(s)

Blood Brain Barrier Disruption - Functional

Blood Brain Barrier Disruption - Functional: Delivery of GCase across the BBB to form a disease modifying strategy for patients with Parkinson's Disease

Study summary

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.

Eligibility

Sex
ALL
Min age
35 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Men or women between age 35 and 80 years, inclusive. * Able and willing to give informed consent. * Diagnosis of PD satisfying MDS Clinical Diagnostic Criteria for PD * At least 2 years from initial diagnosis * Hoehn and Yahr Stage 1-3 on PD medication * Dopaminergic deficit by a positive DAT SPECT scan * On stable regimen of PD medications for at least 90 days prior to the study * American Society of Anesthesiologists (ASA) score 1-3 * Harbor at least one GBA mutation if enrolled in the GBA PD arm or two wild-type GBA alleles if enrolled in the idiopathic PD arm Exclusion Criteria: * Positive pregnancy test (for pre-menopausal women). * Contraindication to DEFINITY ultrasound contrast agent or perflutren (e.g. hypersensitivity, known left or bidirectional cardiac shunt) * Contraindication to MRI or gadolinium-DTPA (e.g. incompatible device, hypersensitivity) * Insulin-dependent diabetes mellitus that is not well-controlled or that in the Investigator's opinion precludes participation in the study. * Severely impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2 and/or on dialysis. * Currently participating in another clinical therapeutic trial * Patient receiving bevacizumab (Avastin) therapy * Subjects with evidence of cranial or systemic infection. * Cerebral or systemic vasculopathy. * Documented cerebral infarction within the past 12 months or TIA in the past 1 month. * Contraindication to GCase enzyme therapy, specifically previous hypersensitivity reaction to GCase enzyme therapy * Parkinsonism plus symptoms, secondary parkinsonism * Previous neurosurgical procedure for PD

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sunybrook Research Institute Toronto Ontario Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05565443 on ClinicalTrials.gov ↗ ← All trials in Canada