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

Sponsor
Mary Phillips, MD MD (Cantab) (Other)
Overall Status
Recruiting
CT.gov ID
NCT05875181
Collaborator
(none)
5
1
2
5
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: tFUS
  • Device: Sham tFUS
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
5 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: VS tFUS/Sham tFUS

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

Device: 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.

Device: 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

Experimental: Sham tFUS/VS tFUS

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

Device: 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.

Device: 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

Outcome Measures

Primary Outcome Measures

  1. Blood oxygen level-dependent (BOLD) signal [30-60 minutes]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • Mary Phillips, MD MD (Cantab)

Investigators

  • Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mary Phillips, MD MD (Cantab), Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT05875181
Other Study ID Numbers:
  • STUDY23020148
First Posted:
May 25, 2023
Last Update Posted:
May 25, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Mary Phillips, MD MD (Cantab), Professor, University of Pittsburgh
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2023