Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 80
Healthy Volunteers: f
View:
• Adults aged 22 to 80 years.
• Diagnosis of idiopathic Parkinson's disease.
• MDS-UPDRS Part III score ≥25 in OFF-medication state at baseline.
• Stable dopaminergic therapy for at least 30 days prior to enrollment.
• English proficiency.
• Normal or corrective hearing and vision.
• Ability to provide informed consent (or availability of an LAR) and comply with protocol requirements.
Locations
United States
California
The Regenesis Project
RECRUITING
Santa Monica
New York
Radial Midtown Manhattan
RECRUITING
New York
Contact Information
Primary
Clinical Team
clinical@sanm.ai
408-455-3817
Time Frame
Start Date: 2025-10-08
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Treatments
Experimental: Active Transcranial Focused Ultrasound
Participants receive active transcranial focused ultrasound neuromodulation targeting the bilateral pallidum. Treatment consists of 20 sessions administered over approximately 4 to 6 weeks. Each session includes bilateral stimulation (15 minutes per hemisphere; 30 minutes total per session). Device parameters are configured to deliver therapeutic ultrasound energy per protocol specifications.
Sham_comparator: Sham Transcranial Focused Ultrasound
Participants undergo procedures identical to the active arm, including device setup, session duration, and visit schedule; however, no therapeutic ultrasound energy is delivered or energy is delivered at sub-therapeutic levels insufficient to produce neuromodulatory effects. This arm is designed to maintain participant and assessor blinding.
Related Therapeutic Areas
Sponsors
Leads: Sanmai Technologies PBC dba Sanmai