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

RecruitingNAAges 22 Years - 80 YearsAllSanmai Technologies PBC dba Sanmai
NCT07207122 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Gen0Bh Transcranial Focused Ultrasound System (Active)
  • Gen0Bh Transcranial Focused Ultrasound System (Sham)
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Where

4 sites
University of Arizona
Tucson, United States
The Regenesis Project
Santa Monica, United States
UF - McKnight Brain Institute
Gainesville, United States
Radial Midtown Manhattan
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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