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NCT07207122
Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
Conditions: Parkinson Disease
Sex: All
Ages: 22 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Sanmai Technologies PBC dba Sanmai
Location: University of Arizona Tucson Arizona
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.
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 \
Source: ClinicalTrials.gov (NCT07207122). StuddyBuddy aggregates publicly available trial information.
