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Recruiting NCT07207122

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

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gen0Bh Transcranial Focused Ultrasound System (Active), Gen0Bh Transcranial Focused Ultrasound System (Sham).
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 22 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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

  • Device Gen0Bh 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.
  • Device Gen0Bh 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.

Primary outcome measures

  • Change in MDS-UPDRS Part III Total Score (OFF Medication State) [Time frame: Baseline up to 6 weeks]
  • Incidence of Serious Adverse Device Events (SADEs) [Time frame: Baseline up to 6 weeks]
Secondary outcome measures (3)
  • Motor Function Assessments [Time frame: Baseline up to 6 weeks]
  • Patient- and Clinician-Reported Outcomes [Time frame: Baseline through Month 3]
  • Psychiatric and Non-Motor Outcomes [Time frame: Baseline through Month 3]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 4 centers
  • University of Arizona — Tucson
  • The Regenesis Project — Santa Monica
  • UF - McKnight Brain Institute — Gainesville
  • Radial Midtown Manhattan — New York

Identifiers

NCT: NCT07207122 · 00085251

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗