Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
Start Date
10/8/2025
Completion Date
12/1/2026
Summary
This is a pilot randomized, sham-controlled, double-blind, multi-center study evaluating the safety and preliminary effectiveness of the Gen0Bh Transcranial Focused Ultrasound System for the treatment of motor symptoms in individuals with idiopathic Parkinson's disease.
Detailed Description
Participants will be randomized in a 1:1 allocation to receive either active or sham stimulation. Both participants and outcome assessors will remain blinded to treatment assignment. The study consists of 20 treatment sessions administered over approximately 4-6 weeks, followed by longitudinal follow-up through 3 months.
Eligibility Criteria
Age Range: 22 years to 80 years
Interventions
Gen0Bh Transcranial Focused Ultrasound System (Active)
Gen0Bh Transcranial Focused Ultrasound System (Sham)
Conditions
Locations
University of Arizona
Tucson, Arizona 85719
United States
The Regenesis Project
Santa Monica, California 90403
United States
UF - McKnight Brain Institute
Gainesville, Florida 32610
United States
Radial Midtown Manhattan
New York, New York 10018
United States