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

Not Applicable

Withdrawn

• Conditions: Impulsive Behavior
• Interventions: Device: tFUS; Device: Sham tFUS

• Registration Number: NCT05875181
• Lead Sponsor: Mary Phillips, MD MD (Cantab)

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.

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-25
• Study Start: 2023-06-19
• Status Verified: 2024-12
• Primary Completion: 2024-12-01
• Study Completion: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tFUS/VS tFUS	tFUS	VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)
VS tFUS/Sham tFUS	tFUS	VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)
VS tFUS/Sham tFUS	Sham tFUS	VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)
Sham tFUS/VS tFUS	Sham tFUS	VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)

Primary Outcome Measures

Name	Time	Method
Blood oxygen level-dependent (BOLD) signal	30-60 minutes	The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States