Dose-Dependent Functional Connectivity Effects of Low-Intensity Focused Ultrasound Applied to Deep White Matter Tracts in Humans
Laureate Institute for Brain Research, Inc.
Summary
Low-intensity focused ultrasound (LIFU) has emerged as a tool to modulate the activity of deep brain structures noninvasively and reversibly, with anatomical precision. Following the results of a pilot study in which the investigators observed target engagement when LIFU was applied to the anterior limb of the internal capsule, the investigators now propose to determine the dose-response relationships of LIFU when applied to deep white matter tracts of the human brain. The investigators hope a successful study will be rapidly translatable into clinical trials seeking to understand mechanistic brain circuit-symptom relationships in major psychiatric disorders.
Description
Low intensity focused ultrasound (LIFU) is a novel technique producing noninvasive, reversible, and anatomically precise neuromodulation of deep structures in the brain. Thus far, it has been successfully employed in humans to modulate the activity of gray matter hubs, including amygdala, thalamus, and cerebral cortex. Burgeoning in vitro data shows that LIFU is also a powerful modulator of axonal conduction, by operating mechanosensitive TRAAK potassium channels in nodes of Ranvier. In a recently completed pilot study (NCT 05697172; FDA non-significant risk), the investigators translated thos…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Age 18 to 65 years. * Body mass index 17-38 kg/m2. * Fluent English speaker, capable of providing written informed consent. * Overall Anxiety Severity and Impairment Scale \<8 and Patient Health Questionnaire-9 \<10 * A person of childbearing potential must have a negative urine pregnancy test at screening * Consent that random observations of pathology are possible (e.g., brain abnormality seen during imaging). Exclusion Criteria: * Inability to provide informed consent including medical, psychiatric, or other conditions that restrict the patient's following abilities…
Interventions
- OtherLow-intensity focused ultrasound
80-second stimulus with an estimated tissue ISSPA=2.26 W/cm2, administered as a single dose (1-epoch), or in multiple doses (3-epoch).
Location
- Laureate Institute for Brain ResearchTulsa, Oklahoma