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RECRUITING

NCT06477029

Examination of Transcranial Focused Ultrasound on Brain Activity in Adults

Sponsor: Mary Phillips, MD MD (Cantab)

View on ClinicalTrials.gov

Summary

The investigators aim to examine the immediate effect of transcranial focused ultrasound (tFUS) on brain activity in healthy adults.

Official title: Modulating Ventral Striatal Activity and Connectivity With Transcranial Focused Ultrasound as a Putative Novel Intervention for Cocaine Use Disorder

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-10-10

Completion Date

2026-04-13

Last Updated

2026-04-07

Healthy Volunteers

Yes

Conditions

Impulsive Behavior

Interventions

DEVICE

tFUS

tFUS is a brief stimulation of a part of the brain called the ventral striatum with low-intensity sound waves that pass through the scalp and skull safely.

DEVICE

Sham tFUS

Sham tFUS goes through the motions of applying tFUS to the brain. Participants will know that one session will be a sham, but they will be blinded to which session is the sham

Inclusion Criteria: * No present/lifetime history of major depressive disorder (MDD), psychosis, Bipolar Disorder; Hamilton Depression Rating Scale (HDRS)\>7; Young Mania Rating Scale (YMRS)\>10), borderline personality disorder, and present suicidal ideation * No family history of MDD, psychosis, Bipolar Disorder, or epilepsy Exclusion Criteria: * Present/lifetime history of MDD, psychosis, Bipolar Disorder (HDRS\>7; YMRS\>10), borderline personality disorder, and present suicidal ideation. Childhood history of, but not present, anxiety disorders and Attention-deficit/hyperactivity disorder (ADHD) will be allowed as these are common disorders in childhood * Family history of MDD, psychosis, Bipolar Disorder, or epilepsy * History of head injury, neurological (e.g., epilepsy), pervasive developmental disorder (e.g., autism), systemic medical disease and treatment (medical records, participant report) * Use of substances with seizure risk (e.g., stimulants) in the past month, as for other non-invasive neuromodulation techniques, assessed as screening and before each tFUS session * Mini-Mental State Examination (MMSE) score (cognitive state) \<24 * Premorbid North American Adult Reading Test (NAART) intelligence quotient (IQ) estimate \<85; * Visual disturbance: \<20/40 (Snellen visual acuity) * Left/mixed handedness (Annett criteria) * History of alcohol or other substance use disorder (SUD), daily nicotine use, and/or illicit substance use over the last 3 months (SCID-5). Note: lifetime/present cannabis use (\<3 times in the past month) at non-SUD levels will be allowed, given its common usage in young adults. Urine tests on scan days will exclude current illicit substance use. Salivary alcohol tests on scan days will exclude intoxicated individuals * Binge drinking (as defined by National Institute on Alcohol Abuse and Alcoholism (NIAA) criteria: consuming 5 or more drinks (male), or 4 or more drinks (female), in about 2 hours.) in the week before, and/or \>3 drinks/day for the 3 days before, and/or alcohol in the last 12 hrs before, any alcohol on tFUS scan day, confirmed at screening and scan days. Alcohol/nicotine/caffeine/cannabis use (below SCID-5 SUD and binge levels) will be allowed * MRI exclusion criteria: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy * Unable to understand English * Taking any psychotropic medications in the past 3 months * Any implanted neural device * Color blind

Locations (1)

UPMC

Pittsburgh, Pennsylvania, United States