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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Sanmai Technologies PBC dba Sanmai
Study ID
NCT07207122
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Oct 3, 2025
Start date
Oct 8, 2025
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Change in MDS-UPDRS Part III Total Score (OFF Medication State) [ Time Frame: Baseline up to 6 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85719
Erica Lord
[email protected]
(520) 866-1033
Alexa Rukstela
[email protected]
(520) 866-1033
John Allen, Ph.D. (PRINCIPAL_INVESTIGATOR)
The Regenesis ProjectSanta MonicaCalifornia90403
Sheena Tan
[email protected]
310-829-5968
Kevin Enemuo
[email protected]
(310) 829-5968
Sheldon E Jordan, MD, FAAN (PRINCIPAL_INVESTIGATOR)
UF - McKnight Brain InstituteGainesvilleFlorida32610
Damon Carpenter
[email protected]
352-294-5837
Andrew O'Shea
[email protected]
(352) 294-8631
Joseph Gullett, Ph.D. (PRINCIPAL_INVESTIGATOR)
Radial Midtown ManhattanNew YorkNew York10018
Angelique Lucien
[email protected]
(516) 908-8540
Ahmed Tahseen, M.D
[email protected]
(516) 908-8540
Owen Muir, M.D (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tucson, AZ

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By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Arizona· Tucson, AZThe Regenesis Project· Santa Monica, CAUF - McKnight Brain Institute· Gainesville, FLRadial Midtown Manhattan· New York, NY

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