Overview
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.
Description
Participants will be randomized in a 1:1 allocation to receive either active or sham stimulation. Both participants and outcome assessors will remain blinded to treatment assignment. The study consists of 20 treatment sessions administered over approximately 4-6 weeks, followed by longitudinal follow-up through 3 months.
Eligibility
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.
