RecruitingNot ApplicableNCT07099950

Dose-Dependent Effects of Low-Intensity Focused Ultrasound

Dose-Dependent Functional Connectivity Effects of Low-Intensity Focused Ultrasound Applied to Deep White Matter Tracts in Humans

Sponsor

Laureate Institute for Brain Research, Inc.

Enrollment

66 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy (Controls)

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

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 Criteria16

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.