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

NCT07207122 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Gen0Bh 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.

DEVICE

Gen0Bh 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.

Sponsors & Collaborators

  • Sanmai Technologies PBC dba Sanmai

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-08
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07207122 on ClinicalTrials.gov