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

Sanmai Technologies PBC dba Sanmai · NCT07207122

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
4
Study start
October 8, 2025
Record last updated
July 31, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Gen0Bh Transcranial Focused Ultrasound System (Active); Gen0Bh Transcranial Focused Ultrasound System (Sham)

Conditions: Parkinson Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of Arizona

    Tucson, AZ 85719

    Site contact: Erica Lord · (520) 866-1033 · ericacook@arizona.edu

  • The Regenesis Project

    Santa Monica, CA 90403

    Site contact: Sheena Tan · 310-829-5968 · stan@theneuroassociates.com

  • UF - McKnight Brain Institute

    Gainesville, FL 32610

    Site contact: Damon Carpenter · 352-294-5837 · carpenter.nb@phhp.ufl.edu

  • Radial Midtown Manhattan

    New York, NY 10018

    Site contact: Angelique Lucien · (516) 908-8540 · ask@meetradial.com

Study contacts (from the official record)

  • Clinical Team · 408-455-3817 · clinical@sanm.ai
All neurology studies in Arizona →
Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on… (NCT07207122) | Bored Studies