LIFUS For Neurological Disorders

Sponsor
University Health Network, Toronto
Study ID
NCT07417280
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • LIFUS — DEVICE
    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 — DEVICE
    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 Details

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.

Key Dates

First listed
Feb 18, 2026
Start date
Dec 2, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2035
Completion
Dec 31, 2040

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

Neurophysiological Effects of Low-Intensity Focused Ultrasound [ Time Frame: Baseline and post-intervention on Day 1 ]

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