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

NCT05875181 | Withdrawn FDA Device

• 1 other identifier: STUDY23020148
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Impulsive Behavior

Keywords

transcranial focused ultrasound; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Blood oxygen level-dependent (BOLD) signal

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

  30-60 minutes

Study Arms (2)

VS tFUS/Sham tFUS

EXPERIMENTAL

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

Device: tFUS; Device: Sham tFUS

Sham tFUS/VS tFUS

EXPERIMENTAL

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

Device: tFUS; Device: Sham tFUS

Interventions

tFUS DEVICE

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/VS tFUS; VS tFUS/Sham tFUS

Sham tFUS DEVICE

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/Sham tFUS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• No psychiatric history

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mary Phillips, MD MD (Cantab): lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Impulsive Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Mary Phillips, MD, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Fabio Ferrarelli, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Khaled Moussawi, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 25, 2023
• Study Start: June 19, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: The principal investigators (PIs) reserve the right to publish on the stated aims in a timely manner. Data will be available for addressing other research questions (i.e. which are not described in funded/pending grants) as soon as the data have been checked for accuracy (a period which will be no later than one year after the completion of each assessment). After the study has ended, the study investigators will continue to test the stated aims, but will also continue to solicit collaborations with outside researchers and to consider data requests in a timely manner.
• Access Criteria: Outside investigators must submit a 1)proposal of the study aims, hypotheses, variables/constructs, analytic approach, and estimated duration of the proposed research; 2)resume, qualifications, source of financial support, and conflict of interest statement; 3)sign a data-sharing agreement and confidentiality statement that stipulates using the data for the stated research purposes only, securing the data using appropriate computer technology, not manipulating the data in order to identify participants, acknowledging the grant that supported data collection and management in publications/presentations, and destroying or returning the data after analyses are complete; 4)obtain approval from their Institutional Review Board, and along with other staff members who have access to the data, submit certificates of the University of Pittsburgh Education and Certification Program in Research Practice Fundamentals or provide written documentation pf similar human subjects protection training.

Locations

US (1)