LIFUS for Parkinson's (NCT07417280)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and 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 10 years and 1 month.
- 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 placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain wave recording (EEG) (non-invasive); Ultrasound (non-invasive). Confirm the full schedule with the study coordinator.