ClinicalTrials.gg
RecruitingNCT07417280Updated Aug 13, 2026

LIFUS For Neurological Disorders

An interventional study of LIFUS and Sham LIFUS in Parkinson's Disease (PD), Essential Tremor and Orthostatic Tremor, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Parkinson's Disease (PD)
  • Essential Tremor
  • Orthostatic Tremor
  • Dystonia
  • Epilepsy
  • Substance Abuse Disorder
  • Deep Brain Stimulation

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
03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 50 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • History of stroke
  • Comorbid dementia
  • Scored below 22 on the (MoCA)
  • Has an implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD)
  • Presence of metal implanted in body that is in TMS/MRI
  • Pregnancy
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Active LIFUS

    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.

    Device: LIFUS

  • Placebo comparator
    Sham LIFUS

    Participants receive sham LIFUS stimulation designed to mimic the experimental condition without delivering therapeutic ultrasound energy.

    Device: Sham LIFUS

Interventions

  • DeviceLIFUS

    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.

  • DeviceSham LIFUS

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and post-intervention on Day 1

  2. 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.

    Time frame: Baseline and post-intervention on Day 1

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07417280
Responsible party
Andres M. Lozano (Dr, University Health Network, Toronto) — Principal investigator
First posted
Feb 18, 2026
Start date
Dec 2, 2025
Primary completion
Dec 31, 2035 (estimated)
Completion
Dec 31, 2040 (estimated)
Last update
Aug 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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