Parkinson DiseaseNCT07207122
Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
A study testing Gen0Bh Transcranial Focused Ultrasound System (Active) in people with Parkinson Disease, run by Sanmai Technologies PBC dba Sanmai at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Gen0Bh Transcranial Focused Ultrasound System (Active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
UF - McKnight Brain Institute
Gainesville, Florida, 32610
Damon Carpenter, 352-294-5837, carpenter.nb@phhp.ufl.edu
Andrew O'Shea, (352) 294-8631, aoshea@phhp.ufl.edu
- Recruiting
Radial Midtown Manhattan
New York, New York, 10018
Angelique Lucien, (516) 908-8540, ask@meetradial.com
Ahmed Tahseen, M.D, (516) 908-8540, ask@meetradial.com
- Recruiting
The Regenesis Project
Santa Monica, California, 90403
Sheena Tan, 310-829-5968 ext. 214, stan@theneuroassociates.com
Kevin Enemuo, (310) 829-5968 ext. 214, kenemuo@theneuroassociates.com
- Recruiting
University of Arizona
Tucson, Arizona, 85719
Erica Lord, (520) 866-1033, ericacook@arizona.edu
Alexa Rukstela, (520) 866-1033, alexarukstela@arizona.edu
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Gen0Bh Transcranial Focused Ultrasound System (Active), Gen0Bh Transcranial Focused Ultrasound System (Sham)
- Keywords
- Low-intensity focused ultrasound neuromodulation, noninvasive neuromodulation, mild cognitive impairment, Parkinson disease dementia, PD, Parkinson, Parkinson disease
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Active Transcranial Focused Ultrasound | Experimental | 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. Receives: Device: Gen0Bh Transcranial Focused Ultrasound System (Active) |
| Sham Transcranial Focused Ultrasound | Sham comparator | 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. Receives: Device: Gen0Bh Transcranial Focused Ultrasound System (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MDS-UPDRS Part III Total Score (OFF Medication State)
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.
Measured: Baseline up to 6 weeks
Incidence of Serious Adverse Device Events (SADEs)
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.
Measured: Baseline up to 6 weeks
Secondary outcomes (3)
Motor Function Assessments
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.
Measured: Baseline up to 6 weeks
Patient- and Clinician-Reported Outcomes
PDQ-39 - Change from baseline in quality of life.
- PGIC - Participant-reported overall improvement.
- CGIC - Clinician-rated overall improvement.
Measured: Baseline through Month 3
Psychiatric and Non-Motor Outcomes
GAD-7 - Change from baseline in anxiety symptoms.
. Beck Depression Inventory - Change from baseline in depressive symptoms.
Measured: Baseline through Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start8 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanmai Technologies PBC dba Sanmai
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207122
- Sponsor's protocol ID
- 00085251
- Status last verified
- Jul 2026
- First submitted
- 26 Sep 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07207122
- Acronym / sponsor ID
- 00085251
- Conditions
- Parkinson Disease
- Keywords
- Low-intensity focused ultrasound neuromodulation, noninvasive neuromodulation, mild cognitive impairment, Parkinson disease dementia, PD, Parkinson, Parkinson disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sanmai Technologies PBC dba SanmaiIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Transcranial Focused Ultrasound | Experimental | Device: Gen0Bh Transcranial Focused Ultrasound System (Active)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 Transcranial Focused Ultrasound | Sham comparator | Device: Gen0Bh Transcranial Focused Ultrasound System (Sham)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. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Active Transcranial Focused Ultrasound |
| 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. | Device | Sham Transcranial Focused Ultrasound |
Primary outcome
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gen0Bh Transcranial Focused Ultrasound System (Active) in people with Parkinson Disease, run by Sanmai Technologies PBC dba Sanmai at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Team (408-455-3817, clinical@sanm.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MDS-UPDRS Part III Total Score (OFF Medication State) (time frame: Baseline up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.