Transcranial Focused Ultrasound (tFUS) Modulation of Reward Network

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT05986019

Collaborator

(none)

Enrollment

Location

Arms

17.1

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: transcranial focused ultrasound (tFUS)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Active or Sham tFUSActive or Sham tFUS

Masking:

Single (Participant)

Masking Description:

Single-blind

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 25, 2023

Anticipated Primary Completion Date :

Jul 25, 2024

Anticipated Study Completion Date :

Dec 25, 2024

Arms and Interventions

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 The sham sessions will include a transducer that is connected in a similar fashion to that of active tFUS, however the cable will not be plugged into the system, thus no ultrasound will be delivered to the participant. 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.

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

The sham sessions will include a transducer that is connected in a similar fashion to that of active tFUS, however the cable will not be plugged into the system, thus no ultrasound will be delivered to the participant. Participants will not know or be told whether they are receiving active- or sham- tFUS.

Device: transcranial focused ultrasound (tFUS)

Outcome Measures

Primary Outcome Measures

Resting State Functional Connectivity [20 minutes]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina Institute of Psychiatry	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

Medical University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bashar Badran, Assistant Professor-Faculty, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT05986019

Other Study ID Numbers:

Pro00127562

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 14, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 14, 2023