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

Recruiting

Who can join

Ages 22 to 80 · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Sanmai Technologies PBC dba Sanmai · Participants: 60 · Started: Oct 8, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07207122

Locations in the U.S.

ArizonaUniversity of Arizona, Tucson
CaliforniaThe Regenesis Project, Santa Monica
FloridaUF - McKnight Brain Institute, Gainesville
New YorkRadial Midtown Manhattan, New York

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.