Excitatory Stimulation for Parkinson's (NCT07695233)
Ultrasound stimulation reduces freezing episodes
- Trial ID
- NCT07695233
- Official Title
- Pedunculopontine Nucleus Transcranial Ultrasound Stimulation as a Treatment of Freezing of Gait in Parkinson's Disease
- Goal
- Ultrasound stimulation reduces freezing episodes
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Robert Chen
- Study Type
- INTERVENTIONAL
- Enrollment
- 50 participants
- Conditions
- Parkinson Disease, Freezing of Gait Symptoms in Parkinson Disease
- Interventions
- Excitatory Stimulation, Inhibitory Stimulation, Sham
Summary For Families
Researchers are testing whether stimulating a small brain area called the pedunculopontine nucleus, which helps control voluntary movement, walking, and muscle tone, can reduce freezing of gait in people with Parkinson's. They use focused ultrasound through the skull to target that area, giving sessions that are excitatory, inhibitory, or sham, and they will measure patient-reported changes, detailed gait analysis, and brain scans before and after to look at changes in how the area connects with the rest of the brain and in blood flow. The study is enrolling adults 18 to 90 who have Parkinson's with freezing of gait and a stable Parkinson's medication dose for at least four weeks; people with prior brain surgery or implanted devices, stroke or seizure history, diagnosed dementia, pregnancy, certain psychiatric conditions or use of antipsychotics or recreational drugs, or incompatible metal implants are not eligible.
Locations
- Toronto Western Hospital, Toronto, Ontario, Canada
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Excitatory Stimulation. Researchers are testing whether stimulating a small brain area called the pedunculopontine nucleus, which helps control voluntary movement, walking, and muscle tone, can reduce freezing of gait in people with Parkinson's. They use focused ultrasound through the skull to target that area, giving sessions that are excitatory, inhibitory, or sham, and they will measure patient-reported changes, detailed gait analysis, and brain scans before and after to look at changes in how the area connects with the rest of the brain and in blood flow. The study is enrolling adults 18 to 90 who have Parkinson's with freezing of gait and a stable Parkinson's medication dose for at least four weeks; people with prior brain surgery or implanted devices, stroke or seizure history, diagnosed dementia, pregnancy, certain psychiatric conditions or use of antipsychotics or recreational drugs, or incompatible metal implants are not eligible.
- Who can participate?
- Participants must be between 18 Years and 90 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 3 years and 6 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.
- How many visits does this trial involve?
- PD patients have Visit 1 and Visits 2-4, with Visits 2-4 spaced at least a week apart.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Ultrasound (non-invasive); MRI scan (non-invasive); Walking & movement tests (non-invasive). Confirm the full schedule with the study coordinator.
- Is there a medication washout in this trial?
- The visits will be spaced at least a week apart to allow for a washout period.