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

Impulsive Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875181
• Other study ID #: STUDY23020148
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University of Pittsburgh
• Contact: Jill Morris-Tillman
• Phone: 412-383-8206
• Email: morristillmanje[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Impulsive Behavior

Intervention

Device:
• tFUS
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.
• Sham tFUS
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

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Mary Phillips, MD MD (Cantab)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood oxygen level-dependent (BOLD) signal	The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity	30-60 minutes