Dose-Dependent Effects of Low-Intensity Focused Ultrasound

Part of paid clinical trials in Tulsa, Oklahoma.

Sponsor
Laureate Institute for Brain Research, Inc.
Study ID
NCT07099950
Status
Recruiting
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Conditions

  • Healthy Controls

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Low-intensity focused ultrasound — OTHER
    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).

Study Details

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.

Key Dates

Start date
Apr 22, 2025
Status verified
Oct 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Single Dose (1-epoch)
    An 80-second train of 20-millisecond bursts of ultrasound (0.5 MHz), repeated every 200 milliseconds (400 bursts). It is estimated a 75% tissue attenuation of energy when the ultrasound wave reaches its target, therefore the investigators will set the free-field Intensity Spatial-Peak Pulse-Average (ISPPA) at 9.04 Watt /cm2 or 518 kPascal (to achieve 2.26 Watt/cm2 estimated derated ISPPA). Any modeling of actual energy delivery will be made a posteriori employing BabelBrain® software embedded in the Brainsight® neuronavigation system.
  • Experimental: Multiple Doses (3-epoch)
    Three 80-second trains of 20-millisecond bursts of ultrasound (0.5 MHz), repeated every 200 milliseconds (400 bursts) will be administered, separated by 30 seconds each. Again, it is estimated a 75% tissue attenuation of energy when the ultrasound wave reaches its target, therefore the investigators will set the free-field Intensity Spatial-Peak Pulse-Average (ISPPA) at 9.04 Watt /cm2 or 518 kPascal (to achieve 2.26 Watt/cm2 derated ISPPA). See above for a posteriori acoustic energy modeling.

Primary Outcome Measure

Post-Sonication Changes in Tissue Engagement [ Time Frame: Pre- vs up to 30 minutes post-sonication for 1-epoch vs 3-epoch LIFU. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Laureate Institute for Brain ResearchTulsaOklahoma74136
Salvador M Guinjoan, MD, PhD
[email protected]
918-502-5119
Danielle E Clark, MA
[email protected]
918-701-9610

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By research site
Laureate Institute for Brain Research· Tulsa, OK

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