LIFUS For Neurological Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity Health Network, Toronto

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

History of stroke

Comorbid dementia

Scored below 22 on the Montreal Cognitive Assessment (MoCA)

Has an implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Active LIFUSExperimental treatment 1 intervention
Group B: Sham LIFUSPlacebo comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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