Dose-Dependent Effects of Low-Intensity Focused Ultrasound
Eligible age
18–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Laureate Institute for Brain Research, Inc.
You may qualify if…
- ✓ 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).
You may not qualify if…
- ✕ 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.
Where it's recruiting
Tulsa
Source: ClinicalTrials.gov · NCT07099950 · last updated 2025-10-16