Transcranial Focused Ultrasound (tFUS) Modulation of Reward Network

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986019
• Other study ID #: Pro00127562
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2023
• Est. completion date: December 25, 2024

Study information

• Verified date: August 2023
• Source: Medical University of South Carolina
• Contact: Bashar Badran, PhD
• Phone: 843-792-6076
• Email: badran[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 25, 2024
• Est. primary completion date: July 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina Institute of Psychiatry	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Functional connectivity "strength calculation" determines whether the activity between a pair of brain regions covaries or correlates over time. We will investigate the strength of the functional connectivity between the stimulation target (Nucleus Accumbens) and connected areas, including the prefrontal cortex, hippocampus, amygdala, and sensory areas of the brain at baseline, and then will determine whether tFUS increases or decreases the resting-state connectivity between these regions after the NAC has been stimulated.	20 minutes