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NCT Number: NCT07207122

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

22 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Regenesis Project, Santa Monica, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in MDS-UPDRS Part III Total Score (OFF Medication State)

    Time frame: 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.

  2. Incidence of Serious Adverse Device Events (SADEs)

    Time frame: 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 outcomes

  1. Motor Function Assessments

    Time frame: 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.

  2. Patient- and Clinician-Reported Outcomes

    Time frame: Baseline through Month 3

    PDQ-39 - Change from baseline in quality of life.

    • PGIC - Participant-reported overall improvement.
    • CGIC - Clinician-rated overall improvement.

  3. Psychiatric and Non-Motor Outcomes

    Time frame: Baseline through Month 3

    GAD-7 - Change from baseline in anxiety symptoms.

    . Beck Depression Inventory - Change from baseline in depressive symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Team

CONTACT

[email protected]

408-455-3817

Sponsors and collaborators

Lead sponsor

Sanmai Technologies PBC dba Sanmai

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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