Transcranial Focused Ultrasound (tFUS) Modulation of Reward Network

Evaluating the Effects of Transcranial Focused Ultrasound (tFUS) on Fronto-striatal Resting State Functional Connectivity in Healthy Individuals

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: transcranial focused ultrasound (tFUS)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina Institute of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active tFUS; tFUS will be administered within the MRI scanner. Participants receive two, 10-min sessions of active tFUS spread 10 min apart targeting the nucleus accumbens.	Device: transcranial focused ultrasound (tFUS); Transcranial focused ultrasound (tFUS) is a promising new technology that is both noninvasive and may be focally applied to deep brain targets. tFUS utilizes transducers which contain piezoelectric elements to produce pulses of ultrasonic waves that summate deep in the brain. Transcranial focused ultrasound (tFUS) uses a single transducer fixed in a head-worn apparatus on the scalp to produce ultrasonic waves deep into the brain.
Sham Comparator: Sham tFUS; No ultrasound will be delivered to the participant during the experiment. Participants will not know or be told whether they are receiving active- or sham- tFUS.	Device: transcranial focused ultrasound (tFUS); Transcranial focused ultrasound (tFUS) is a promising new technology that is both noninvasive and may be focally applied to deep brain targets. tFUS utilizes transducers which contain piezoelectric elements to produce pulses of ultrasonic waves that summate deep in the brain. Transcranial focused ultrasound (tFUS) uses a single transducer fixed in a head-worn apparatus on the scalp to produce ultrasonic waves deep into the brain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting State Functional Connectivity	The main outcomes of this study are brain imaging related. Using a neuroimaging technique called resting state functional connectivity, which is a statistical dependence between time series of electro-physiological activity and (de)oxygenated blood levels in distinct regions of the brain. Modularity is measured on a -1 to 1 scale, with higher scores indicating stronger community structure, or a stronger tendency of clusters of brain regions to separate into distinct, highly interconnected networks with sparse connections across networks. The optimal modularity value depends on the context. For example, during complex tasks lower modularity is better, while during basic, automatic tasks higher modularity is better.	24 minutes

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Actual): October 6, 2023
• Study Completion (Actual): June 27, 2024

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Pro00127562

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No