Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry

Study Overview
=================
Brief Summary
-----------------
The investigators aim to examine the immediate effect of transcranial focused ultrasound (tFUS) on brain activity and emotions in healthy adults as a first stage toward understanding the predisposing brain mechanisms of underlying substance use disorders.

Detailed Description
-----------------
In a small pilot study the investigators propose to demonstrate feasibility of using tFUS to target the ventral striatum (VS) in humans by examining VS target engagement by tFUS in healthy human volunteers using a reward processing task that reliably activates the VS.

Official Title
-----------------
Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry

Conditions
-----------------
Impulsive Behavior

Intervention / Treatment
-----------------
* Device: tFUS
* Device: Sham tFUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-35 years of age No psychiatric history Exclusion Criteria: Not between 18-35 years of age Has psychiatric history History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report) Mini-Mental State Examination (MMSE) score (cognitive state) <24 Premorbid North American Adult Reading Test (NAART) intelligent quotient (IQ) estimate<85 Visual disturbance: <20/40 Snellen visual acuity Left/mixed handedness (Annett criteria) History of alcohol/substance use disorder (SUD) (all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (Structured Clinical Interview for Diagnostic and Statistic Manual of Mental Disorders , 5th Edition (DSM-5) (SCID-5)). Urine tests on scan days will exclude current illicit substance use (except cannabis). Salivary alcohol tests on scan days will exclude intoxicated individuals Magnetic resonance imaging (MRI) exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy Unable to understand English Individuals with a positive pregnancy test will be excluded from the study and not undergo a computerized tomography (CT) scan or MRI scan Present or history of seizure disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VS tFUS/Sham tFUS<br>VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS) | Device: tFUS<br>* tFUS is a brief stimulation of a part of the brain called the ventral striatum with low-intensity sound waves that pass through the scalp and skull safely.<br>Device: Sham tFUS<br>* Sham tFUS goes through the motions of applying tFUS to the brain. Participants will know that one session will be a sham, but they will be blinded to which session is the sham<br>|
| Experimental: Sham tFUS/VS tFUS<br>VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS) | Device: tFUS<br>* tFUS is a brief stimulation of a part of the brain called the ventral striatum with low-intensity sound waves that pass through the scalp and skull safely.<br>Device: Sham tFUS<br>* Sham tFUS goes through the motions of applying tFUS to the brain. Participants will know that one session will be a sham, but they will be blinded to which session is the sham<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood oxygen level-dependent (BOLD) signal | The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity | 30-60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transcranial focused ultrasound, Magnetic Resonance Imaging