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RecruitingParkinson Disease

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

Eligible age

22–80 yrs

Accepts

All genders

Locations

4 states

Healthy volunteers

No

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About this 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.

Sponsor: Sanmai Technologies PBC dba Sanmai

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.

Where it's recruiting

Arizona

Tucson

California

Santa Monica

Florida

Gainesville

New York

New York

Source: ClinicalTrials.gov · NCT07207122 · last updated 2026-07-31