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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05875181
Other study ID # STUDY23020148
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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