Transcranial Focused Ultrasound for Parkinson's Disease

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

Recruiting N/A Interventional Study
Parkinson Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
22 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Sanmai Technologies PBC dba Sanmai · Industry
Who this trial is looking for

This trial is looking for adults with Parkinson's disease to test a new treatment called transcranial focused ultrasound. Participants will receive the treatment and be monitored for safety and effectiveness.

Are You a Good Fit for This Trial?
Must be taking Dopaminergic therapy
Rules you out Severe psychiatric illnessSignificant neurologic diseasesActive malignancy

You may be able to join if

  • I am between 22 and 80 years old.
  • I have been diagnosed with idiopathic Parkinson's disease.
  • My MDS-UPDRS Part III score is 25 or higher while off medication.
  • I have been on stable dopaminergic therapy for at least 30 days.
  • I can speak and understand English.
  • I have normal or corrected hearing and vision.
  • I am able to give informed consent.

You may not be able to join if

  • I have atypical or secondary Parkinsonism.
  • I have had deep brain stimulation or intracranial surgery.
  • My MoCA score is below 23.
  • I have severe psychiatric illness.
  • I have a history of seizures or brain issues.
  • I have significant neurologic diseases.
  • I cannot have an MRI or ultrasound.
  • I am currently pregnant or breastfeeding.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

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.

Trial Locations
Loading…

Loading trial locations…

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 visi…
Contacts

Clinical Team

408-455-3817

clinical@sanm.ai

CONTACT