Clinical trial NCT05875181: Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry
Official title: Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Impulsive Behavior
Keywords: transcranial focused ultrasound
Magnetic Resonance Imaging
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Blood oxygen level-dependent (BOLD) signal
timeFrame: 30-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Mary Phillips, MD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Fabio Ferrarelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Khaled Moussawi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: