Examination of Transcranial Focused Ultrasound on Brain Activity in Adults

NCT ID: NCT06477029

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-10
• Study Completion Date: 2026-03-15

Brief Summary

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

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.

Conditions

Impulsive Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

VS tFUS/Sham tFUS

VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)

Group Type: EXPERIMENTAL

tFUS

Intervention Type: DEVICE

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.

Sham tFUS

Intervention Type: DEVICE

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

Sham tFUS/VS tFUS

VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)

Group Type: EXPERIMENTAL

tFUS

Intervention Type: DEVICE

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.

Sham tFUS

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

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
• Unable to understand English
• Taking any psychotropic medications in the past 3 months
• Any implanted neural device
• Color blind

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Mary Phillips, MD MD (Cantab)

OTHER

Sponsor Role: lead

Responsible Party

Mary Phillips, MD MD (Cantab)

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mary P Phillips, MD MD (Cantab)

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jill Morris-Tillman

Role: CONTACT

fmristudies@upmc.edu

4123838206

Facility Contacts

Jill Morris-Tillman

Role: primary

Phillips_Lab@umpc.edu

4123838206

Other Identifiers

UG3DA060431

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY24020142

Identifier Type: -

Identifier Source: org_study_id