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Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry

Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05875181
Enrollment
0
Registered
2023-05-25
Start date
2023-06-19
Completion date
2024-12-31
Last updated
2024-12-13

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

Brief summary

The investigators aim to examine the immediate effect of transcranial focused ultrasound (tFUS) on brain activity and emotions in healthy adults as a first stage toward understanding the predisposing brain mechanisms of underlying substance use disorders.

Detailed description

In a small pilot study the investigators propose to demonstrate feasibility of using tFUS to target the ventral striatum (VS) in humans by examining VS target engagement by tFUS in healthy human volunteers 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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* 18-35 years of age * No psychiatric history

Exclusion criteria

* Not between 18-35 years of age * Has psychiatric history * History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report) * Mini-Mental State Examination (MMSE) score (cognitive state) \<24 * Premorbid North American Adult Reading Test (NAART) intelligent quotient (IQ) estimate\<85 * Visual disturbance: \<20/40 Snellen visual acuity * Left/mixed handedness (Annett criteria) * History of alcohol/substance use disorder (SUD) (all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (Structured Clinical Interview for Diagnostic and Statistic Manual of Mental Disorders , 5th Edition (DSM-5) (SCID-5)). Urine tests on scan days will exclude current illicit substance use (except cannabis). Salivary alcohol tests on scan days will exclude intoxicated individuals * Magnetic resonance imaging (MRI) exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy * Unable to understand English * Individuals with a positive pregnancy test will be excluded from the study and not undergo a computerized tomography (CT) scan or MRI scan * Present or history of seizure disorder

Design outcomes

Primary

MeasureTime frameDescription
Blood oxygen level-dependent (BOLD) signal30-60 minutesThe blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026