Gen0Bh Transcranial Focused Ultras… for Parkinson's (NCT07207122)
Reduce tremor using sound waves
- Trial ID
- NCT07207122
- Official Title
- Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
- Goal
- Reduce tremor using sound waves
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Sanmai Technologies PBC dba Sanmai
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease
- Interventions
- Gen0Bh Transcranial Focused Ultrasound System (Active), Gen0Bh Transcranial Focused Ultrasound System (Sham)
- Registry Record Last Updated
- 2026-07-31 (this month)
- Estimated Commitment
- Moderate commitment estimated from the protocol (based on: 20 study visits, placebo or control group). This reflects time and procedures only — confirm details with the study coordinator.
Summary For Families
Researchers are testing whether a device that delivers focused ultrasound to the head can safely and preliminarily improve motor symptoms in people with idiopathic, or typical, Parkinson's disease. Participants are randomly assigned to get either active or sham (inactive) stimulation, with 20 sessions over about 4 to 6 weeks and follow-up for 3 months, and neither participants nor outcome assessors know who got which. The study plans to enroll 60 adults aged 22 to 80 who have a confirmed Parkinson's diagnosis, a motor exam score of 25 or higher when off medication, and who have been on stable Parkinson's medications for at least 30 days. People with prior deep brain stimulation or other brain surgery, low cognitive scores, a history of seizures or major brain disease, serious psychiatric illness, contraindications to MRI or ultrasound, or pregnancy are not eligible.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Medication dose: Must be on a stable dose of Parkinson's medication (criteria text: "Stable dopaminergic therapy for at least 30 days prior to enrollment.")
- Deep brain stimulation: Cannot join after DBS surgery (deep brain stimulation) (criteria text: "* prior deep brain stimulation or intracranial surgery")
- Thinking test (MoCA): MoCA memory and thinking score of at least 23 (criteria text: "MoCA score \<23.")
- Movement score (MDS-UPDRS): MDS-UPDRS movement score of at least 25 (criteria text: "* mds-updrs part iii score >=25 in off-medication state at baseline")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial enrolls people aged 22 to 80.
- This trial does not enroll people who have had (or are scheduled for) DBS surgery.
- This trial requires a MoCA thinking-test score of at least 23.
Locations
- University of Arizona, Tucson, Arizona, United States
- The Regenesis Project, Santa Monica, California, United States
- UF - McKnight Brain Institute, Gainesville, Florida, United States
- Radial Midtown Manhattan, New York, New York, United States
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07207122. It is the one about "Reduce tremor using sound waves". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: The study requires 20 treatment sessions over approximately 4-6 weeks, with follow-up through 3 months. Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Whether you are placed in the sham group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the sham group would be.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Gen0Bh Transcranial Focused Ultrasound System (Active). Researchers are testing whether a device that delivers focused ultrasound to the head can safely and preliminarily improve motor symptoms in people with idiopathic, or typical, Parkinson's disease. Participants are randomly assigned to get either active or sham (inactive) stimulation, with 20 sessions over about 4 to 6 weeks and follow-up for 3 months, and neither participants nor outcome assessors know who got which. The study plans to enroll 60 adults aged 22 to 80 who have a confirmed Parkinson's diagnosis, a motor exam score of 25 or higher when off medication, and who have been on stable Parkinson's medications for at least 30 days. People with prior deep brain stimulation or other brain surgery, low cognitive scores, a history of seizures or major brain disease, serious psychiatric illness, contraindications to MRI or ultrasound, or pregnancy are not eligible.
- Who can participate?
- Participants must be between 22 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 4 locations.
- Does it cost anything to join?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 2 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Whether you are placed in the sham group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the sham group would be.
- How many visits does this trial involve?
- The study requires 20 treatment sessions over approximately 4-6 weeks, with follow-up through 3 months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Ultrasound (non-invasive). Confirm the full schedule with the study coordinator.