Sound waves reduce movement stiffness
- Trial ID
- NCT07207122
- Official Title
- Effects of Transcranial Focused Ultrasound Stimulation (tFUS) on Neurological and Cognitive Outcomes in Parkinson's Disease
- Goal
- Sound waves reduce movement stiffness
- 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)
Summary For Families
The goal is to see whether noninvasive focused ultrasound can improve both motor symptoms and thinking in people with Parkinson's, using motor scores and cognitive tests as main outcomes. The approach uses the Gen0Bh transcranial focused ultrasound system, which sends low‑intensity, focused sound waves through the skull to temporarily change how neurons fire in targeted brain regions, and participants are randomized to active or sham stimulation. It is tested as an add-on to standard dopaminergic therapy like levodopa, so it does not replace your medications and may help with responsiveness or OFF-period severity if effective. The trial is looking for adults 22 to 80 with idiopathic Parkinson's, an OFF-state MDS-UPDRS Part III score of at least 25, stable dopaminergic meds for 30 or more days, MoCA 23 or above, and no prior DBS, seizures, major psychiatric illness, or MRI/ultrasound contraindications.
Locations
- The Regenesis Project, Santa Monica, California, United States
- Radial Midtown Manhattan, New York, New York, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Gen0Bh Transcranial Focused Ultrasound System (Active). The goal is to see whether noninvasive focused ultrasound can improve both motor symptoms and thinking in people with Parkinson's, using motor scores and cognitive tests as main outcomes. The approach uses the Gen0Bh transcranial focused ultrasound system, which sends low‑intensity, focused sound waves through the skull to temporarily change how neurons fire in targeted brain regions, and participants are randomized to active or sham stimulation. It is tested as an add-on to standard dopaminergic therapy like levodopa, so it does not replace your medications and may help with responsiveness or OFF-period severity if effective. The trial is looking for adults 22 to 80 with idiopathic Parkinson's, an OFF-state MDS-UPDRS Part III score of at least 25, stable dopaminergic meds for 30 or more days, MoCA 23 or above, and no prior DBS, seizures, major psychiatric illness, or MRI/ultrasound contraindications.
- Who can participate?
- Participants must be between 22 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 2 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.