NCT07207122Recruiting
Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 26 Sept 2025
- Start date
- Oct 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Sanmai Technologies PBC dba Sanmai
- Diseases
- Parkinson disease
- NCT number
- NCT07207122
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Oct 2025 to the primary completion date, Dec 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior deep brain stimulation or intracranial surgery.
Other illness
- 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)
- Unstable systemic medical conditions.
- Active malignancy or history of cancer within the past 5 years.
Other
- Atypical or secondary Parkinsonism.
- MoCA score \<23.
- Contraindication to MRI or ultrasound.
- Pregnancy or breastfeeding.
- Participation in another interventional trial.
Who the study is looking for
- 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.
Age in the registry: 22 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UF - McKnight Brain Institute Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Radial Midtown Manhattan Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| The Regenesis Project Coordinator of this site? Confirm its status | Santa Monica | United States | Recruiting |
| University of Arizona Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.