NCT07099950 Dose-Dependent Effects of Low-Intensity Focused Ultrasound

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This trial targets 66 participants in total. It began in 2025-04-22 with a primary completion date of 2026-08.

Brief Summary

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.

Eligibility 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.

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