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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Parkinson Disease

In brief

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 facts

Study ID

NCT07207122

Run by

Sanmai Technologies PBC dba Sanmai

People needed

60

Starts

2025-10-08

Expected to finish

2026-12-01

Last updated by the study team

2026-07-31

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arizona — Tucson, Arizona, United States (enrolling)
• The Regenesis Project — Santa Monica, California, United States (enrolling)
• UF - McKnight Brain Institute — Gainesville, Florida, United States (enrolling)
• Radial Midtown Manhattan — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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