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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
LIFUS
DeviceLow-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
DeviceSham 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
Trial 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.
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.
Sponsors and contacts
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