Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
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.
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
- Age range
- 22–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * Atypical or secondary Parkinsonism. * Prior deep brain stimulation or intracranial surgery. * MoCA score \<23. * Severe psychiatric illness (e.g., psychosis, suicidali…
Interventions
- DeviceGen0Bh 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.
- DeviceGen0Bh 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 ProjectSanta Monica, California
- Radial Midtown ManhattanNew York, New York