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)
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.
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). 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 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.
- 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. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- 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.