Examination of Transcranial Focused Ultrasound on Brain Activity in Adults

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

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

Study Overview

• Status: Completed
• Conditions: Impulsive Behavior
• Intervention / Treatment: Device: tFUS; Device: Sham tFUS

Detailed Description

The investigators will examine ventral striatum (VS) target engagement by tFUS in healthy adults using a reward processing task that reliably activates the VS.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VS tFUS/Sham tFUS; VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)	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
Experimental: Sham tFUS/VS tFUS; VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventral striatum (VS) activity to prediction error before receiving tFUS to the VS	Measure of ventral striatum (VS) activity to prediction error before receiving tFUS to the VS	Two visits over up to 8 weeks
Ventral striatum (VS) activity to prediction error after receiving tFUS to the VS	Measure of ventral striatum (VS) activity to prediction error after receiving tFUS to the VS	Two visits over up to 8 weeks

Collaborators and Investigators

• Sponsor: Mary Phillips, MD MD (Cantab)
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Mary P Phillips, MD MD (Cantab), University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Actual): April 13, 2026
• Study Completion (Actual): April 13, 2026

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Reward; transcranial focused ultrasound
• Additional Relevant MeSH Terms: Behavior; Impulsive Behavior
• Other Study ID Numbers: STUDY24020142; UG3DA060431 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this study will be available for access by the research community via National Institute of Mental Health Data Archive (NDA).
• IPD Sharing Time Frame: After each submission cycle, NDA conducts quality assurance (QA) procedures on submitted data during which access to data and images for research is temporarily suspended, typically a period lasting 4 months prior to sharing. As required by NDA, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available. NDA studies have digital object identifiers (DOI) to aid findability. We will include DOI in relevant publications. NDA will decide how long to preserve the data, but has not deleted any deposited data to date.
• IPD Sharing Access Criteria: To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No