MR-guided Focused Ultrasound Plus GCase
ConditionParkinsons Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-80
SponsorInSightec
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Blood Brain Barrier Disruption - Functional
Treatment groups
14 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov