Actively Recruiting
Dose-Dependent Effects of Low-Intensity Focused Ultrasound
Led by Laureate Institute for Brain Research, Inc. · Updated on 2025-10-16
66
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 between 17 and 38 kg/m2.
- Fluent English speaker able to provide written informed consent.
- Overall Anxiety Severity and Impairment Scale score less than 8 and Patient Health Questionnaire-9 score less than 10.
- Negative urine pregnancy test for persons of childbearing potential at screening.
- Consent to possible discovery of incidental brain abnormalities during imaging.
You will not qualify if you...
- Unable to provide informed consent due to medical, psychiatric, or other conditions.
- No telephone or easy access to a telephone.
- Active suicidal thoughts or recent suicide attempts within the last 3 months.
- Positive test for substance abuse or disorder including alcohol, stimulants, sedatives, and cannabis exceeding mild severity in the last 6 months.
- Lifetime diagnosis of major psychiatric disorders including depression, anxiety, bipolar, schizophrenia, or obsessive-compulsive disorder.
- Use of benzodiazepines or anticonvulsants within 7 days before participation.
- MRI contraindications such as claustrophobia or inability to lie still for 60 minutes.
- History of structural brain diseases like Parkinson's disease, multiple sclerosis, or brain tumors.
- Unstable or significant medical conditions affecting liver, kidney, heart, lungs, gastrointestinal, endocrine, neurological, blood, rheumatological, or metabolic systems.
- Moderate to severe traumatic brain injury or neurocognitive disorders.
- Use of psychotropic medications.
- Prior brain surgery.
- Uncorrectable vision or hearing problems.
AI-Screening
AI-Powered Screening
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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
CONTACT
D
Danielle E Clark, MA
CONTACT
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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