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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Sham LIFUS | Placebo Comparator | Participants receive sham LIFUS stimulation designed to mimic the experimental condition without delivering therapeutic ultrasound energy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital, 399 Bathurst St | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020329 | Essential Tremor |
| D004421 | Dystonia |
| D004827 | Epilepsy |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |