Parkinson's Disease (PD)NCT07417280
LIFUS For Neurological Disorders
A study testing LIFUS in people with Parkinson's Disease (PD) and Essential Tremor, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Low intensity focused ultrasound (LIFUS) has the potential to be used as a means of non-invasive neuro-modulation. To this day, the use of LIFUS is under investigation. Studies in healthy subjects have shown that application of LIFUS to the motor region of the brain can mildly decrease neuron excitability in healthy… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease (PD), Essential Tremor, Orthostatic Tremor
- What is being tested?
- LIFUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 2 Dec 2025to 31 Dec 2040
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-85 years of age
- Patients diagnosed with neurological disorders, (such as epilepsy, brain tumour, movement disorders) or psychiatric disorders (such as substance abuse disorder)
- Patients undergoing medical or surgical treatment (such as DBS) for neurological disorders
Who cannot join
- History of stroke
- Comorbid dementia
- Scored below 22 on the Montreal Cognitive Assessment (MoCA)
- Has an implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD)
- Presence of metal implanted in body that is contraindicated in TMS/MRI
- Pregnancy
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- Major depression/psychiatric disorder that in the opinion of the Investigator will affect patient's understanding of study procedures and willingness to abide by all procedures during the course of the study
- Receiving a psychotropic medication or taking recreational substances that in the opinion of the investigator will significantly affect safety of the protocol
- Major systemic illness or infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital, 399 Bathurst St
Toronto, Ontario, M5T 2S8
Alyssa Schleifer, 416-603-5800 ext. 2797, Neurosurgery.Research@uhn.ca
Tasnuva Hoque, 416-603-5800 ext. 3421, Neurosurgery.Research@uhn.ca
About this study
Official title: Clinical Effects of Low-Intensity Focused Ultrasound Neuromodulation in Patients With Neurological and Psychiatric Disorders
Low intensity focused ultrasound (LIFUS) has the potential to be used as a means of non-invasive neuro-modulation. To this day, the use of LIFUS is under investigation. Studies in healthy subjects have shown that application of LIFUS to the motor region of the brain can mildly decrease neuron excitability in healthy controls. The purpose of the present study is to evaluate the effects of LIFUS on brain tissue excitability in patients with movement disorders in order to elucidate the therapeutic potential of LIFUS.
- Conditions
- Parkinson's Disease (PD), Essential Tremor, Orthostatic Tremor, Dystonia, Epilepsy, Substance Abuse Disorder
- Being tested
- LIFUS, Sham LIFUS
- Keywords
- Parkinson's Disease, Essential Tremor, Orthostatic Tremor, Dystonia, Epilepsy, Substance Abuse Disorder, Deep Brain Stimulation, DBS, Substance Use Disorder, SUD, PD, LIFUS, Low-Intensity Focused Ultrasound, Neuromodulation
- Medical subject headings
- Parkinson Disease, Essential Tremor, Dystonia, Epilepsy, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFUSDevice
Low-intensity focused ultrasound neuromodulation delivered to targeted cortical and/or subcortical brain regions to transiently modulate neural activity. LIFUS may be applied alone or in combination with concurrent neurophysiological assessments (e.g., TMS-evoked motor evoked potentials, EEG recordings, or DBS local field potential sensing) depending on the study component.
Sham LIFUSDevice
Sham low-intensity focused ultrasound stimulation designed to mimic the sensory and procedural aspects of active LIFUS without delivering therapeutic ultrasound energy. The sham condition serves as a control to maintain blinding of participants and investigators.
| Study group | Role | What they receive |
|---|---|---|
| Active LIFUS | Experimental | Participants receive low-intensity focused ultrasound neuromodulation (LIFUS) targeting cortical or subcortical brain regions, with or without concurrent TMS or EEG/DBS recordings, depending on the study component. Receives: Device: LIFUS |
| Sham LIFUS | Placebo comparator | Participants receive sham LIFUS stimulation designed to mimic the experimental condition without delivering therapeutic ultrasound energy. Receives: Device: Sham LIFUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurophysiological Effects of Low-Intensity Focused Ultrasound
To determine whether LIFUS applied to cortical and subcortical brain regions modulates neurophysiological activity, as measured by suppression of transcranial magnetic stimulation-evoked motor evoked potentials and elicitation of local field potentials recorded from implanted deep brain stimulation devices (e.g., Medtronic Percept), following active LIFUS compared to sham stimulation.
Measured: Baseline and post-intervention on Day 1
Change in Clinical and Behavioral Function Following LIFUS
To determine whether LIFUS stimulation produces measurable changes in clinical measures of motor function and behavior, including tremor amplitude, bradykinesia, rigidity, fine motor control, affective state, and craving-related behaviors, following active LIFUS compared to sham stimulation.
Measured: Baseline and post-intervention on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start2 Dec 2025
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres M. Lozano, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417280
- Sponsor's protocol ID
- 19-6139
- Status last verified
- Aug 2026
- First submitted
- 30 Jan 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No