Actively Recruiting
Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
Led by Sanmai Technologies PBC dba Sanmai · Updated on 2026-05-11
60
Participants Needed
2
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Atypical or secondary Parkinsonism.
- Prior deep brain stimulation or intracranial surgery.
- MoCA score <23.
- Severe psychiatric illness such as psychosis, suicidality, or untreated major depression.
- History of seizure or intracranial pathology.
- Significant neurological diseases like brain tumor or multiple sclerosis.
- Contraindications to MRI or ultrasound.
- Unstable systemic medical conditions.
- Active malignancy or cancer history within the past 5 years.
- Pregnancy or breastfeeding.
- Participation in another interventional trial.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The Regenesis Project
Santa Monica, California, United States, 90403
Actively Recruiting
2
Radial Midtown Manhattan
New York, New York, United States, 10018
Actively Recruiting
Research Team
C
Clinical Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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