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Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
Sponsor: Sanmai Technologies PBC dba Sanmai
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.
Key Details
Gender
All
Age Range
22 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-10-08
Completion Date
2026-12
Last Updated
2026-05-11
Healthy Volunteers
No
Conditions
Interventions
Gen0Bh Transcranial Focused Ultrasound System (Active)
The investigational Gen0Bh system delivers noninvasive, transcranial focused ultrasound to modulate neural activity in the bilateral globus pallidus. Stimulation parameters, including frequency, intensity, and duty cycle, are pre-specified and controlled by the device software. Treatments are administered by trained study personnel in a clinical setting over 20 sessions across approximately 4 to 6 weeks.
Gen0Bh Transcranial Focused Ultrasound System (Sham)
The sham configuration uses the same device platform and mimics all procedural aspects of active treatment, including acoustic coupling, device setup, and session duration, without delivering therapeutic ultrasound energy to the target region. This approach is designed to maintain participant and assessor blinding.
Locations (2)
The Regenesis Project
Santa Monica, California, United States
Radial Midtown Manhattan
New York, New York, United States