Deep Brain Stimulation, Dystonia, Epilepsy, Essential Tremor, Orthostatic Tremor, Parkinson's Disease (PD), Substance Abuse Disorder
Conditions
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
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.
Interventions
DEVICELIFUS
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.
DEVICESham 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.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurophysiological Effects of Low-Intensity Focused Ultrasound | Baseline and post-intervention on Day 1 | 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. |
| Change in Clinical and Behavioral Function Following LIFUS | Baseline and post-intervention on Day 1 | 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. |
Countries
Canada
Outcome results
None listed