Actively Recruiting
Dose-Dependent Functional Connectivity Effects of Low-Intensity Focused Ultrasound Applied to Deep White Matter Tracts in Humans
Led by Laureate Institute for Brain Research, Inc. · Updated on 2025-10-16
66
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the dose-dependent effects of low-intensity focused ultrasound (LIFU) on deep white matter tracts in the human brain. This study aims to understand how different doses of LIFU influence brain circuit activity, with the goal of advancing mechanistic studies linking brain function and behavior in psychiatric disorders. The study builds on prior pilot results showing that LIFU can modulate brain activity noninvasively and precisely. The trial involves 60 healthy adults who will be randomly assigned to receive either a single 80-second ultrasound session or three 80-second sessions separated by 30 seconds. The LIFU targets specific white matter tracts connecting the thalamus with key brain regions involved in emotion and cognition, using carefully measured ultrasound intensities. Dose effects on brain function will be studied using advanced imaging and modeling techniques. Participants will undergo brain imaging before and up to 30 minutes after LIFU to assess changes in brain connectivity and activity. Researchers will measure how the ultrasound affects brain circuits and how these effects relate to baseline brain structure and function. The study includes careful monitoring of participant health and uses questionnaires to ensure safety. Overall, the study will last long enough to capture immediate brain changes after ultrasound exposure.
CONDITIONS
Brief Title
Dose-Dependent Effects of Low-Intensity Focused Ultrasound
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 less than 8 and Patient Health Questionnaire-9 less than 10.
- Negative urine pregnancy test at screening for persons of childbearing potential.
- Consent to possible incidental findings during imaging (e.g., brain abnormalities).
You will not qualify if you...
- Inability to provide informed consent due to medical, psychiatric, or other conditions.
- No telephone or easy access to telephone.
- Active suicidal thoughts or recent suicide attempt.
- Positive test for substance abuse or substance use disorder in the last 6 months.
- Lifetime diagnosis of major psychiatric disorders including major depression, anxiety disorders, schizophrenia, bipolar disorder, PTSD, or OCD.
- Use of benzodiazepines or anticonvulsants within 7 days prior to participation.
- MRI contraindications such as claustrophobia or inability to remain still for scans.
- History of structural brain pathology or neurocognitive disorders.
- Unstable medical conditions affecting liver, kidney, heart, lungs, endocrine, neurological, hematological, rheumatological, or metabolic systems.
- Moderate to severe traumatic brain injury.
- Use of psychotropic medications.
- Prior neurosurgery.
- Non-correctable vision or hearing impairments.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session lasting approximately 30 minutes
Participants receive low-intensity focused ultrasound (LIFU) neuromodulation applied to deep brain white matter tracts with either a single 80-second dose or three 80-second doses separated by 30 seconds to study dose-dependent effects.
1 in-person treatment visit
Duration - Up to 30 minutes post-treatment
Participants are observed for changes in brain functional connectivity and tissue engagement for up to 30 minutes following LIFU treatment.
Continuous monitoring during treatment visit
Trial Site Locations
Total: 1 location
1
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
Research Team
S
Salvador M Guinjoan, MD, PhD
D
Danielle E Clark, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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