N/A
N=10
Transcranial Focused Ultrasound (tFUS) Modulation of Reward Network
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05986019 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Resting State Functional Connectivity — 0.069; 0.160 z value
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- transcranial focused ultrasound (tFUS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resting State Functional Connectivity |
0.069; 0.160 | — |
Summary
Aim: Evaluate whether sonicating the Nucleus Accumbens (NAc) with transcranial focused ultrasound modifies functional connectivity between the NAc and the prefrontal cortex (PFC).
In this single visit, open-label pilot trial, we plan to evaluate whether transcranial focused ultrasound (tFUS), delivered to the nucleus accumbens (NAc) within the magnetic resonance imaging (MRI) scanner will impact resting state functional connectivity between the NAc and functionally connected brain regions like the prefrontal cortex (PFC) and the anterior cingulate cortex (ACC) in up to 10 healthy individuals.
HYPOTHESIS : tFUS will reduce prefrontal cortex (PFC)-NAc functional connectivity, in healthy individuals. We will investigate this hypothesis by administering tFUS within to MRI scanner to healthy individuals and conduct resting state functional neuroimaging before- and after the tFUS stimulation.
Eligibility Criteria
Inclusion Criteria
- Age 18-65
- Have the capacity and ability to provide one's own consent and sign the informed consent document
Exclusion Criteria
- Contraindicated for MRI.
- Any current or recent untreated medical, neurological, or psychiatric conditions
- Metal implant devices in the head, heart, or neck.
- History of brain surgery.
- History of myocardial infarction or arrhythmia, bradycardia.
- Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium).
- Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
- Individuals suffering from frequent/severe headaches.
- Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic.
- Regular or recent pain medication use
- Moderate to severe alcohol use (>3 drinks/day) or illicit substance use (urine confirmed).
- Persons who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT05986019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.