Examination of Transcranial Focused Ultrasound on Brain Activity in Adults

NCT06477029 | Completed FDA Device

• 2 other identifiers: STUDY24020142UG3DA060431
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Impulsive Behavior

Keywords

transcranial focused ultrasound; Magnetic Resonance Imaging; Reward

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

VS tFUS/Sham tFUS

EXPERIMENTAL

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

Device: tFUS; Device: Sham tFUS

Sham tFUS/VS tFUS

EXPERIMENTAL

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

Device: tFUS; Device: Sham tFUS

Interventions

tFUS 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/VS tFUS; VS tFUS/Sham tFUS

Sham tFUS 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/Sham tFUS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mary Phillips, MD MD (Cantab): lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Impulsive Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Mary P Phillips, MD MD (Cantab)

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 27, 2024
• Study Start: October 10, 2024
• Primary Completion: April 13, 2026
• Study Completion: April 13, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

US (1)