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Clinical Trials/NCT05875181
NCT05875181
Withdrawn
Not Applicable

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

Mary Phillips, MD MD (Cantab)1 site in 1 country5 target enrollmentJune 19, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Impulsive Behavior
Sponsor
Mary Phillips, MD MD (Cantab)
Enrollment
5
Locations
1
Primary Endpoint
Blood oxygen level-dependent (BOLD) signal
Status
Withdrawn
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 19, 2023
End Date
December 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mary Phillips, MD MD (Cantab)
Responsible Party
Sponsor Investigator
Principal Investigator

Mary Phillips, MD MD (Cantab)

Professor

University of Pittsburgh

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

Outcomes

Primary Outcomes

Blood oxygen level-dependent (BOLD) signal

Time Frame: 30-60 minutes

The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity

Study Sites (1)

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