Transcranial Focused Ultrasound (tFUS) Modulation of Reward Network

NCT ID: NCT05986019

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-25
• Study Completion Date: 2024-06-27

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

transcranial focused ultrasound (tFUS)

Intervention Type: DEVICE

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 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.

Group Type: SHAM_COMPARATOR

transcranial focused ultrasound (tFUS)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of South Carolina Institute of Psychiatry

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00127562

Identifier Type: -

Identifier Source: org_study_id