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OpenTrials
Completed

NCT Number: NCT06477029

Examination of Transcranial Focused Ultrasound on Brain Activity in Adults

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Ventral striatum (VS) activity to prediction error before receiving tFUS to the VS

    Time frame: Two visits over up to 8 weeks

    Measure of ventral striatum (VS) activity to prediction error before receiving tFUS to the VS

  2. Ventral striatum (VS) activity to prediction error after receiving tFUS to the VS

    Time frame: Two visits over up to 8 weeks

    Measure of ventral striatum (VS) activity to prediction error after receiving tFUS to the VS

Sponsors and collaborators

Lead sponsor

Mary Phillips, MD MD (Cantab)

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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