Dose-Dependent Effects of Low-Intensity Focused Ultrasound
Laureate Institute for Brain Research, Inc. · NCT07099950
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–65 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 66
- US sites recruiting
- 1
- Study start
- April 22, 2025
- Record last updated
- October 16, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Low-intensity focused ultrasound
Conditions: Healthy Controls
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or complete the study.
- No telephone or easy access to telephone
- Has active suicidal ideation (as measured by Suicide-Risk-Assessment-C-SSRS "Yes" answers to items 3, 4, or 5 Suicidal Ideation-Past 1 month section, or any "Yes" answer to any of the items of Suicidal Behavior-Past 3 months section), or any suicide attempt in the last 3 months
- Has positive test result(s) for alcohol of abuse (including methadone, opiates, cocaine, amphetamine/methamphetamine and ecstasy), or substance use disorder including alcohol, stimulants, sedatives, and cannabis exceeding mild severity in the last 6 months
- Has a lifetime APA Diagnostic and Statistical Manual of Mental Disorders (DSM)-5th edition including major depression, generalized anxiety disorder, specific phobias, panic disorder, post-traumatic stress disorder, schizophrenia spectrum and other psychotic disorders, obsessive-compulsive disorder, or bipolar disorder.
- Benzodiazepines or anticonvulsants in the 7 days prior to participation.
- MRI contradictions as detected by the MRI Safety Screen including claustrophobia and unwillingness and inability to complete scans (e.g., unable to lie on one's back for 60 mins.
- Clinical history of relevant structural pathology of the central nervous system, including Parkinson's disease, multiple sclerosis, and brain malignant neoplasia.
- History of unstable liver or renal insufficiency; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatological, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit or confound the protocol-specified assessments, including uncontrolled diabetes mellitus (ss evidenced by fasting glycemia ≥ 120 mg/dL or hemoglobin A1c ≥ 6.5%) or hypertension (as evidenced by two consecutive readings ≥ 140/90 mmHg) to ensure medical stability throughout this longitudinal study.
- Moderate-to-severe traumatic brain injury or any other clinical neurocognitive disorder.
- Clinical history of at least minor neurocognitive disorder of any origin.
- Prescription of a medication outside of the accepted range, as determined by best clinical practices and current research.
- Use of any psychotropic medication.
- Unwillingness or inability to complete any major aspects of the study protocol.
- Prior neurosurgery.
- Non-correctable vision or hearing.
Recruiting US locations
Laureate Institute for Brain Research
Tulsa, OK 74136
Site contact: Salvador M Guinjoan, MD, PhD · 918-502-5119 · sguinjoan@laureateinstitute.org
Study contacts (from the official record)
- Salvador M Guinjoan, MD, PhD · 918-502-5119 · sguinjoan@laureateinstitute.org
- Danielle E Clark, MA · 918-701-9610 · dclark@laureateinstitute.org
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