MR-Guided Focused Ultrasound + GCase for Parkinson's Disease
Trial Summary
Do I need to stop my current medications for this trial?
The trial requires that you have been on a stable regimen of Parkinson's disease medications for at least 90 days before the study, so you should not stop taking your current medications.
What data supports the effectiveness of this treatment for Parkinson's Disease?
Is MR-guided Focused Ultrasound safe for humans?
MR-guided Focused Ultrasound (MRgFUS) has been used safely in humans for conditions like Parkinson's disease and essential tremor, with studies showing it as an incisionless (no cutting) treatment option. While some side effects have been noted, the procedure is generally considered safe based on experiences from multiple treatments.13467
How is the MR-guided Focused Ultrasound Plus GCase treatment different from other Parkinson's disease treatments?
What is the purpose of this trial?
This trial aims to test a new treatment for Parkinson's Disease by delivering an enzyme directly into the brain using MRI and focused ultrasound. It targets patients with genetic or unknown causes of Parkinson's. The enzyme may help reduce harmful substances in the brain and improve symptoms. Focused ultrasound combined with microbubbles is becoming a promising technology for the treatment of central nervous system diseases, including Parkinson's Disease.
Eligibility Criteria
This trial is for men and women aged 35-75 with Parkinson's Disease diagnosed at least 2 years ago, at stages 1-3 on medication. Participants must have a positive DAT SPECT scan, be on stable PD meds for over 90 days, and either carry a GBA mutation or not, depending on the study arm. Exclusions include pregnancy, severe kidney issues, other clinical trials participation, hypersensitivity to certain agents used in the study or MRI contrasts.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive three transcranial bilateral putamenal GCase treatments at 30 IU/kg IV every two weeks, followed by 60 IU/kg in the next three subjects
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Blood Brain Barrier Disruption - Functional
- MR-guided Focused Ultrasound Plus GCase
MR-guided Focused Ultrasound Plus GCase is already approved in United States, European Union, Canada for the following indications:
- Essential Tremor
- Parkinson's disease-related tremor
- Essential Tremor
- Parkinson's disease-related tremor
- Essential Tremor
- Parkinson's disease-related tremor
Find a Clinic Near You
Who Is Running the Clinical Trial?
InSightec
Lead Sponsor
Dr. Maurice R. Ferré
InSightec
Chief Executive Officer
MD
Dr. Arjun Desai
InSightec
Chief Medical Officer
MD