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NCT07207122

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

Recruiting
NAAges 22–80InterventionalTreatment
Sanmai Technologies PBC dba Sanmai
~60 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Gen0Bh Transcranial Focused Ultrasound System (Active)Gen0Bh Transcranial Focused Ultrasound System (Sham)

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in MDS-UPDRS Part III Total Score (OFF Medication State)
Measured over Baseline up to 6 weeks
+1 more outcome measured

Conditions

Parkinson Disease

Explore related trials

Parkinson Disease

NCT07207122

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Radial Midtown Manhattan

    New York, New Yorkstudy coordinator listed

    Recruiting

  • The Regenesis Project

    Santa Monica, Californiastudy coordinator listed

    Recruiting

  • UF - McKnight Brain Institute

    Gainesville, Floridastudy coordinator listed

    Recruiting

  • University of Arizona

    Tucson, Arizonastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Clinical Team
[email protected]
408-455-3817
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

Atypical or secondary Parkinsonism.
Prior deep brain stimulation or intracranial surgery.
MoCA score \<23.
Severe psychiatric illness (e.g., psychosis, suicidality, untreated major depression).
History of seizure or intracranial pathology.
Significant neurologic disease (e.g. brain tumor, multiple sclerosis)
Contraindication to MRI or ultrasound.
Unstable systemic medical conditions.
Active malignancy or history of cancer within the past 5 years.
Pregnancy or breastfeeding.
Participation in another interventional trial.

What this trial measures

  • Change in MDS-UPDRS Part III Total Score (OFF Medication State)Baseline up to 6 weeks

    The MDS-UPDRS Part III is a clinician-administered assessment of motor function in Parkinson's disease. It includes 18 items with 33 individual ratings, each scored from 0 (normal) to 4 (severe), with a total score range of 0 to 132. Higher scores indicate worse motor impairment. Assessments will be conducted in the OFF-medication state by trained, blinded raters using standardized procedures. The outcome measure is defined as the change from baseline in total score at post-treatment milestones (after Sessions 5, 10, 15, and 20), comparing active versus sham groups.

  • Incidence of Serious Adverse Device Events (SADEs)Baseline up to 6 weeks

    Number and proportion of participants experiencing Serious Adverse Device Events (SADEs), including severity and relationship to the investigational device, assessed from baseline through completion of 20 treatment sessions.