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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
The investigational Gen0Bh system delivers noninvasive, transcranial focused ultrasound to modulate neural activity in the bilateral globus pallidus. Stimulation parameters, including frequency, intensity, and duty cycle, are pre-specified and controlled by the device software. Treatments are administered by trained study personnel in a clinical setting over 20 sessions across approximately 4 to 6 weeks.
The sham configuration uses the same device platform and mimics all procedural aspects of active treatment, including acoustic coupling, device setup, and session duration, without delivering therapeutic ultrasound energy to the target region. This approach is designed to maintain participant and assessor blinding.
University of Arizona
Tucson, Arizona, United States
RECRUITINGThe Regenesis Project
Santa Monica, California, United States
RECRUITINGUF - McKnight Brain Institute
Gainesville, Florida, United States
RECRUITINGChange in MDS-UPDRS Part III Total Score (OFF Medication State)
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.
Time frame: Baseline up to 6 weeks
Incidence of Serious Adverse Device Events (SADEs)
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.
Time frame: Baseline up to 6 weeks
Motor Function Assessments
Finger Tapping Test - Change from baseline in tapping speed and amplitude. * 10-Meter Timed Walk Test - Change from baseline in time required to walk 10 meters. * Archimedean Spiral Test - Change from baseline in tremor severity based on spiral drawing performance. * Timed Up and Go (TUG) - Change from baseline in time required to stand, walk, turn, and sit.
Time frame: Baseline up to 6 weeks
Patient- and Clinician-Reported Outcomes
PDQ-39 - Change from baseline in quality of life. * PGIC - Participant-reported overall improvement. * CGIC - Clinician-rated overall improvement.
Time frame: Baseline through Month 3
Psychiatric and Non-Motor Outcomes
GAD-7 - Change from baseline in anxiety symptoms. . Beck Depression Inventory - Change from baseline in depressive symptoms.
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Radial Midtown Manhattan
New York, New York, United States
RECRUITINGTime frame: Baseline through Month 3