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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06477029
Enrollment
25
Registered
2024-06-27
Start date
2024-10-10
Completion date
2026-04-13
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impulsive Behavior

Keywords

transcranial focused ultrasound, Magnetic Resonance Imaging, Reward

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.

Interventions

DEVICEtFUS

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.

DEVICESham 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

Sponsors

Mary Phillips, MD MD (Cantab)
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ventral striatum (VS) activity to prediction error before receiving tFUS to the VSTwo visits over up to 8 weeksMeasure of ventral striatum (VS) activity to prediction error before receiving tFUS to the VS
Ventral striatum (VS) activity to prediction error after receiving tFUS to the VSTwo visits over up to 8 weeksMeasure of ventral striatum (VS) activity to prediction error after receiving tFUS to the VS

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMary P Phillips, MD MD (Cantab)

University of Pittsburgh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026