LIFUS For Neurological Disorders

NCT07417280 | Recruiting

• 1 other identifier: 19-6139
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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; 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and post-intervention on Day 1

Study Arms (2)

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.

Device: LIFUS

Sham LIFUS

PLACEBO COMPARATOR

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

Device: Sham LIFUS

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.

Active LIFUS

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.

Sham LIFUS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital, 399 Bathurst St

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Dystonia; Epilepsy; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 18, 2026
• Study Start: December 2, 2025
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2040
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

CA (1)