Using focused ultrasound to study brain activity related to impulsive behavior

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

This study is testing if a special ultrasound treatment can change brain activity related to impulsive behavior in healthy adults during a reward task.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 31 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: University of Pittsburgh (other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT06477029 on ClinicalTrials.gov

What this trial studies

This study investigates the immediate effects of transcranial focused ultrasound (tFUS) on brain activity in healthy adults, specifically targeting the ventral striatum (VS) during a reward processing task. Participants will undergo either active tFUS or sham tFUS to assess how this intervention influences brain engagement in relation to impulsive behavior. The study aims to provide insights into the neural mechanisms underlying impulsivity and reward processing.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults without a history of major psychiatric disorders or neurological conditions.

Not a fit: Patients with a history of major depressive disorder, psychosis, bipolar disorder, or other significant neurological issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of impulsive behavior and lead to new therapeutic approaches for related conditions.

How similar studies have performed: While the use of tFUS is a novel approach, similar studies have shown promise in understanding brain activity, though this specific application is less explored.

Eligibility criteria

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

Where this trial is running

Pittsburgh, Pennsylvania

• UPMC — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Mary P Phillips, MD MD (Cantab) — University of Pittsburgh
• Study coordinator: Jill Morris-Tillman

Conditions: Impulsive Behavior, transcranial focused ultrasound, Magnetic Resonance Imaging, Reward