LIFUS For Neurological Disorders

University Health Network, Toronto50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Parkinson's Disease (PD)Essential Tremor Orthostatic Tremor Dystonia Epilepsy

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.