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

Mary Phillips, MD MD (Cantab)

Status: Withdrawn

Conditions: Impulsive Behavior

Treatments: Device: Sham tFUS; Device: tFUS

Study type: Interventional

Funder types: Other

Identifiers

NCT05875181

STUDY23020148

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

VS tFUS/Sham tFUS

Experimental group

Description:

VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)

Treatment:

Device: tFUS

Device: Sham tFUS

Sham tFUS/VS tFUS

Experimental group

Description:

VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)

Treatment:

Device: tFUS

Device: Sham tFUS