Transcranial focused ultrasound for motor and cognitive symptoms in Parkinson's disease

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

This pilot will test whether noninvasive low‑intensity focused ultrasound can improve motor symptoms and thinking problems in people with idiopathic Parkinson's disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 22 Years to 80 Years
• Sex: All
• Sponsor: Sanmai Technologies PBC dba Sanmai (Industry-sponsored)
• Locations: 2 sites (Santa Monica, California and 1 other locations)
• Trial ID: NCT07207122 on ClinicalTrials.gov

What this trial studies

This is a randomized, double‑blind, sham‑controlled pilot using the Gen0Bh transcranial focused ultrasound system in people with idiopathic Parkinson's disease. Participants are randomized 1:1 to active or sham stimulation and receive 20 treatment sessions over approximately 4–6 weeks, with follow‑up through three months. The study measures safety and preliminary effects on motor function (MDS‑UPDRS Part III) and cognitive outcomes while keeping participants and outcome assessors blinded. Key enrollment requirements include ages 22–80, an MDS‑UPDRS Part III ≥25 in the off‑medication state, MoCA ≥23, and stable dopaminergic therapy.

Who should consider this trial

Good fit: Ideal candidates are adults 22–80 with idiopathic Parkinson's disease, significant motor symptoms (MDS‑UPDRS Part III ≥25 off medication), MoCA ≥23, stable dopaminergic therapy, and the ability to attend frequent treatment visits.

Not a fit: Patients with atypical or secondary parkinsonism, significant cognitive impairment (MoCA <23), prior DBS or intracranial surgery, seizure history, MRI/ultrasound contraindications, active recent cancer, or unstable medical/psychiatric conditions are unlikely to benefit or will be excluded.

Why it matters

Potential benefit: If successful, this approach could provide a noninvasive therapy to reduce motor symptoms and possibly improve cognition without brain surgery.

How similar studies have performed: Low‑intensity focused ultrasound neuromodulation is an emerging technology with promising animal data and a few small human reports, but it remains largely experimental and unproven for Parkinson's motor and cognitive symptoms.

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 vision.
* Ability to provide informed consent (or availability of an LAR) and comply with protocol requirements.

Exclusion Criteria:

* 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.

Where this trial is running

Santa Monica, California and 1 other locations

• The Regenesis Project — Santa Monica, California, United States (Recruiting)
• Radial Midtown Manhattan — New York, New York, United States (Recruiting)

Study contacts

• Study coordinator: Clinical Team

Conditions Parkinson Disease; Low-intensity focused ultrasound neuromodulation; noninvasive neuromodulation; mild cognitive impairment; Parkinson disease dementia; PD; Parkinson; Parkinson disease