Reduce tremor with focused ultrasound
- Trial ID
- NCT07417280
- Official Title
- Clinical Effects of Low-Intensity Focused Ultrasound Neuromodulation in Patients With Neurological and Psychiatric Disorders
- Goal
- Reduce tremor with focused ultrasound
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University Health Network, Toronto
- Study Type
- INTERVENTIONAL
- Enrollment
- 50 participants
- Conditions
- Parkinson's Disease (PD), Essential Tremor, Orthostatic Tremor, Dystonia, Epilepsy, Substance Abuse Disorder, Deep Brain Stimulation
- Interventions
- LIFUS, Sham LIFUS
Summary For Families
Low-intensity focused ultrasound, or LIFUS, is being tested to gently change the activity of the brain circuits that drive Parkinson's motor symptoms like tremor and stiffness, offering a noninvasive complement to medicines or surgery. The device sends focused sound waves through the skull to increase or decrease neuron firing in a targeted spot, it is compared with a sham procedure, and it does not deliver drugs so it can be used alongside levodopa or existing DBS rather than replacing them. Adults 18 to 85 with Parkinson's or other neurological or psychiatric conditions can enroll, but people with prior stroke, dementia or a MoCA under 22, certain implanted metal devices or pacemakers, pregnancy, major uncontrolled psychiatric illness, or serious systemic illness are excluded.
Locations
- Toronto Western Hospital, 399 Bathurst St, Toronto, Ontario, Canada
Frequently Asked Questions
- What is this trial testing?
- This trial is studying LIFUS. Low-intensity focused ultrasound, or LIFUS, is being tested to gently change the activity of the brain circuits that drive Parkinson's motor symptoms like tremor and stiffness, offering a noninvasive complement to medicines or surgery. The device sends focused sound waves through the skull to increase or decrease neuron firing in a targeted spot, it is compared with a sham procedure, and it does not deliver drugs so it can be used alongside levodopa or existing DBS rather than replacing them. Adults 18 to 85 with Parkinson's or other neurological or psychiatric conditions can enroll, but people with prior stroke, dementia or a MoCA under 22, certain implanted metal devices or pacemakers, pregnancy, major uncontrolled psychiatric illness, or serious systemic illness are excluded.
- Who can participate?
- Participants must be between 18 Years and 85 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 10 years and 1 month.
- 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.