Recruiting

LIFUS

Sponsor:

University Health Network, Toronto

Code:

NCT07417280

Conditions

Parkinson's Disease (PD)

Essential Tremor

Orthostatic Tremor

Dystonia

Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

LIFUS

Sham LIFUS

Study Details

Brief 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.

Conditions

Parkinson's Disease (PD)

Essential Tremor

Orthostatic Tremor

Dystonia

Epilepsy

Study ID

NCT07417280

Start date

Dec 2, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2040

Anticipated

Primary completion date

Dec 31, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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:

  • 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
  • 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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

placebo comparator: Sham LIFUS

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

Interventions

LIFUS

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 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.

Primary outcome measure

  • Neurophysiological Effects of Low-Intensity Focused Ultrasound [ Time Frame: Baseline and post-intervention on Day 1 ]
  • Change in Clinical and Behavioral Function Following LIFUS [ Time Frame: Baseline and post-intervention on Day 1 ]

Central Contacts and Locations

Locations

Toronto Western Hospital, 399 Bathurst St

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Alyssa Schleifer

416-603-5800Neurosurgery.Research@uhn.ca

Tasnuva Hoque

416-603-5800Neurosurgery.Research@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-08-13.