Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease

NCT07207122 | Recruiting

• 1 other identifier: 00085251
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

Parkinson Disease

Keywords

Low-intensity focused ultrasound neuromodulation; noninvasive neuromodulation; mild cognitive impairment; Parkinson disease dementia; PD; Parkinson; Parkinson disease

Outcome Measures

Primary Outcomes (2)

• Change 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.

  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.

  Baseline up to 6 weeks

Secondary Outcomes (3)

• Motor Function Assessments

  Baseline up to 6 weeks

• Patient- and Clinician-Reported Outcomes

  Baseline through Month 3

• Psychiatric and Non-Motor Outcomes

  Baseline through Month 3

Study Arms (2)

Active Transcranial Focused Ultrasound

EXPERIMENTAL

Participants receive active transcranial focused ultrasound neuromodulation targeting the bilateral pallidum. Treatment consists of 20 sessions administered over approximately 4 to 6 weeks. Each session includes bilateral stimulation (15 minutes per hemisphere; 30 minutes total per session). Device parameters are configured to deliver therapeutic ultrasound energy per protocol specifications.

Device: Gen0Bh Transcranial Focused Ultrasound System (Active)

Sham Transcranial Focused Ultrasound

SHAM COMPARATOR

Participants undergo procedures identical to the active arm, including device setup, session duration, and visit schedule; however, no therapeutic ultrasound energy is delivered or energy is delivered at sub-therapeutic levels insufficient to produce neuromodulatory effects. This arm is designed to maintain participant and assessor blinding.

Device: Gen0Bh Transcranial Focused Ultrasound System (Sham)

Interventions

Gen0Bh Transcranial Focused Ultrasound System (Active) DEVICE

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.

Active Transcranial Focused Ultrasound

Gen0Bh Transcranial Focused Ultrasound System (Sham) DEVICE

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.

Sham Transcranial Focused Ultrasound

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanmai Technologies PBC dba Sanmai: lead

Study Sites (4)

University of Arizona

Tucson, Arizona, 85719, United States

RECRUITING

The Regenesis Project

Santa Monica, California, 90403, United States

RECRUITING

UF - McKnight Brain Institute

Gainesville, Florida, 32610, United States

RECRUITING

Radial Midtown Manhattan

New York, New York, 10018, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Clinical Team

CONTACT

408-455-3817; clinical@sanm.ai

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)