Recruiting

Transcranial Focused Ultrasound

Sponsor:

Sanmai Technologies PBC dba Sanmai

Code:

NCT07207122

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Gen0Bh Transcranial Focused Ultrasound System (Active)

Gen0Bh Transcranial Focused Ultrasound System (Sham)

Study Details

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

Study ID

NCT07207122

Start date

Oct 8, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Transcranial Focused Ultrasound

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.

sham comparator: Sham Transcranial Focused Ultrasound

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.

Interventions

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Clinical Team

408-455-3817clinical@sanm.ai

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Erica Lord

(520) 866-1033ericacook@arizona.edu

Alexa Rukstela

(520) 866-1033alexarukstela@arizona.edu

Principal Investigator:

John Allen, Ph.D.

The Regenesis Project

Recruiting

Santa Monica, California, United States, 90403

Contacts

Sheena Tan

310-829-5968stan@theneuroassociates.com

Kevin Enemuo

(310) 829-5968kenemuo@theneuroassociates.com

Principal Investigator:

Sheldon E Jordan, MD, FAAN

UF - McKnight Brain Institute

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Damon Carpenter

352-294-5837carpenter.nb@phhp.ufl.edu

Andrew O'Shea

(352) 294-8631aoshea@phhp.ufl.edu

Principal Investigator:

Joseph Gullett, Ph.D.

Radial Midtown Manhattan

Recruiting

New York, New York, United States, 10018

Contacts

Angelique Lucien

(516) 908-8540ask@meetradial.com

Ahmed Tahseen, M.D

(516) 908-8540ask@meetradial.com

Principal Investigator:

Owen Muir, M.D

More Information

Sponsor

Sanmai Technologies PBC dba Sanmai

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sanmai Technologies PBC dba Sanmai on 2026-07-31.