MR-guided Focused Ultrasound Plus GCase

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  35 to 80

Participation Criteria

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