Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry
NCT ID: NCT05875181
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-06-19
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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VS tFUS/Sham tFUS
VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)
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
Sham tFUS/VS tFUS
VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* No psychiatric history
Exclusion Criteria
* 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
18 Years
35 Years
ALL
Yes
Sponsors
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Mary Phillips, MD MD (Cantab)
OTHER
Responsible Party
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Mary Phillips, MD MD (Cantab)
Professor
Principal Investigators
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Mary Phillips, MD, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Fabio Ferrarelli, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Khaled Moussawi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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STUDY23020148
Identifier Type: -
Identifier Source: org_study_id