ClinicalTrials.gg
CompletedNCT06477029Updated Jun 11, 2026

Examination of Transcranial Focused Ultrasound on Brain Activity in Adults

An interventional study of tFUS and Sham tFUS in Impulsive Behavior, sponsored by Mary Phillips, MD MD (Cantab). Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Mary Phillips, MD MD (Cantab) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Impulsive Behavior

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Keywords

  • transcranial focused ultrasound
  • Magnetic Resonance Imaging
  • Reward
03

In context

Impulsive Behavior

158 studies on the registry are indexed under Impulsive Behavior; 31 are open to participants now.

This study's enrollment of 25 is below the median of 50 across 128 interventional studies indexed under Impulsive Behavior.

Browse Impulsive Behavior studies →

Lead sponsor

Mary Phillips, MD MD (Cantab) is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
25 participants (actual)

Study arms

  • 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 · Device: Sham tFUS

  • 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 · Device: Sham tFUS

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Two visits over up to 8 weeks

  2. 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

    Time frame: Two visits over up to 8 weeks

07

Study locations

1 site
  • UPMC
    Pittsburgh, Pennsylvania 15213, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Data from this study will be available for access by the research community via National Institute of Mental Health Data Archive (NDA).

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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06477029
Lead sponsor
Mary Phillips, MD MD (Cantab)
Responsible party
Mary Phillips, MD MD (Cantab) (Professor, University of Pittsburgh) — Sponsor-investigator
First posted
Jun 27, 2024
Start date
Oct 10, 2024
Primary completion
Apr 13, 2026
Completion
Apr 13, 2026
Last update
Jun 11, 2026

Study contacts

Mary P Phillips, MD MD (Cantab)
principal investigator · University of Pittsburgh

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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