MR-guided Focused Ultrasound Plus GCase

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a two-arm, open-label, intervention only phase I/II clinical study. One arm of the study will enroll seven (7) GBA PD patients and the other arm seven (7) idiopathic PD patients. During the intervention phase, the first four subjects of each arm will receive three transcranial bilateral putamenal GCase at 30 IU/kg IV every two weeks, followed by 60 IU/kg in the next three subjects. Following three treatments in this study, the subjects will be followed for twelve months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05565443
Study type	Interventional
Source	InSightec
Contact	Nadir Alikacem
Phone	+12146302000
Email	nadira@insightec.com
Status	Recruiting
Phase	N/A
Start date	November 30, 2022
Completion date	December 31, 2024

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