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NCT07207122NARecruiting

Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease

Sanmai Technologies PBC dba Sanmai

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

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, suicidality, untreated major depression). * History of seizure or intracranial pathology. * Significant neurologic disease (e.g. brain tumor, multiple sclerosis) * Contraindication to MRI or ultrasound. * Unstable systemic medical conditions. * Active malignancy or history of cancer within the past 5 years. * Pregnancy or breastfeeding. * Participation in another interventional trial.

Interventions

DEVICE

Gen0Bh Transcranial Focused Ultrasound System (Active)

DEVICE

Gen0Bh Transcranial Focused Ultrasound System (Sham)

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Conditions

Parkinson Disease

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