RecruitingNot ApplicableNCT07207122

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


Sponsor

Sanmai Technologies PBC dba Sanmai

Enrollment

60 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 22 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing transcranial ultrasound stimulation (TUS) — a non-invasive brain stimulation technique that uses focused sound waves — to see if it can improve thinking, memory, and neurological function in people with Alzheimer's disease, Parkinson's disease, or mild cognitive impairment. **You may be eligible if...** - You are 18–80 years old - You have been clinically diagnosed with Alzheimer's disease, Parkinson's disease, Parkinson's dementia, or mild cognitive impairment - You can read and understand English - You have normal or corrected-to-normal vision and hearing - You are medically stable as assessed by the research team **You may NOT be eligible if...** - You have implanted metal devices or a pacemaker that are incompatible with the TUS or MRI technology - You have uncontrolled heart conditions or a history of recent heart attack - You have a significant unrelated neurological disorder (beyond the target disease) - You have a psychiatric diagnosis such as OCD, psychosis, or bipolar disorder - You have a history of epilepsy or multiple seizures - You have had recent brain surgery or significant brain injury - You have used recreational drugs within the past month Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGen0Bh Transcranial Focused Ultrasound System (Active)

The investigational Gen0Bh system delivers noninvasive, transcranial focused ultrasound to modulate neural activity in the bilateral globus pallidus. Stimulation parameters, including frequency, intensity, and duty cycle, are pre-specified and controlled by the device software. Treatments are administered by trained study personnel in a clinical setting over 20 sessions across approximately 4 to 6 weeks.

DEVICEGen0Bh Transcranial Focused Ultrasound System (Sham)

The sham configuration uses the same device platform and mimics all procedural aspects of active treatment, including acoustic coupling, device setup, and session duration, without delivering therapeutic ultrasound energy to the target region. This approach is designed to maintain participant and assessor blinding.


Locations(2)

The Regenesis Project

Santa Monica, California, United States

Radial Midtown Manhattan

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT07207122


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