Parkinson Disease
Conditions
Keywords
Low-intensity focused ultrasound neuromodulation, noninvasive neuromodulation, mild cognitive impairment, Parkinson disease dementia, PD, Parkinson, Parkinson disease
Brief summary
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.
Detailed 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.
Interventions
DEVICEGen0Bh Transcranial Focused Ultrasound System (Sham)
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.
DEVICEGen0Bh Transcranial Focused Ultrasound System (Active)
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.
Sponsors
Sanmai Technologies PBC dba Sanmai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in MDS-UPDRS Part III Total Score (OFF Medication State) | Baseline up to 6 weeks | 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. |
| Incidence of Serious Adverse Device Events (SADEs) | Baseline up to 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor Function Assessments | Baseline up to 6 weeks | 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. |
| Patient- and Clinician-Reported Outcomes | Baseline through Month 3 | PDQ-39 - Change from baseline in quality of life. * PGIC - Participant-reported overall improvement. * CGIC - Clinician-rated overall improvement. |
| Psychiatric and Non-Motor Outcomes | Baseline through Month 3 | GAD-7 - Change from baseline in anxiety symptoms. . Beck Depression Inventory - Change from baseline in depressive symptoms. |
Countries
United States
Contacts
CONTACTClinical Team
Outcome results
None listed