MR-guided Focused Ultrasound Plus GCase

Korábbi kezelés

• Patient receiving bevacizumab (Avastin) therapy
• Contraindication to GCase enzyme therapy, specifically previous hypersensitivity reaction to GCase enzyme therapy
• Previous neurosurgical procedure for PD

Más betegség

• 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.
• Subjects with evidence of cranial or systemic infection.

Egyéb

• Positive pregnancy test (for pre-menopausal women).
• 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
• Cerebral or systemic vasculopathy.
• Documented cerebral infarction within the past 12 months or TIA in the past 1 month.
• Parkinsonism plus symptoms, secondary parkinsonism

• 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