Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
Recruiting · NCT07207122 · Interventional (participants receive a specific treatment) · Lead sponsor: Sanmai Technologies PBC dba Sanmai
View the official record on ClinicalTrials.gov →Interventions studied
Gen0Bh Transcranial Focused Ultrasound System (Active)Gen0Bh Transcranial Focused Ultrasound System (Sham)
What this trial is about
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.
Who can take part
Age range
22 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
4 locations listed across 4 US states.
- University of Arizona - Tucson, Arizona, United States
- The Regenesis Project - Santa Monica, California, United States
- UF - McKnight Brain Institute - Gainesville, Florida, United States
- Radial Midtown Manhattan - New York, New York, United States