Back to resultsExamining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry
Primary Purpose
Impulsive Behavior
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tFUS
Sham tFUS
Sponsored by
About this trial
This is an interventional basic science trial for Impulsive Behavior focused on measuring transcranial focused ultrasound, Magnetic Resonance Imaging
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 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
Sites / Locations
- University of Pittsburgh Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
VS tFUS/Sham tFUS
Sham tFUS/VS tFUS
Arm Description
VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)
VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)
Outcomes
Primary Outcome Measures
Blood oxygen level-dependent (BOLD) signal
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Secondary Outcome Measures
Full Information
NCT ID
NCT05875181
First Posted
April 24, 2023
Last Updated
July 5, 2023
Sponsor
Mary Phillips, MD MD (Cantab)
1. Study Identification
Unique Protocol Identification Number
NCT05875181
Brief Title
Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry
Official Title
Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mary Phillips, MD MD (Cantab)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impulsive Behavior
Keywords
transcranial focused ultrasound, Magnetic Resonance Imaging
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VS tFUS/Sham tFUS
Arm Type
Experimental
Arm Description
VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)
Arm Title
Sham tFUS/VS tFUS
Arm Type
Experimental
Arm Description
VS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS)
Intervention Type
Device
Intervention Name(s)
tFUS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham tFUS
Intervention Description
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
Primary Outcome Measure Information:
Title
Blood oxygen level-dependent (BOLD) signal
Description
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Time Frame
30-60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Morris-Tillman
Phone
412-383-8206
Email
morristillmanje@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Phillips, MD, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fabio Ferrarelli, MD, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Khaled Moussawi, MD, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Morris-Tillman
Phone
412-383-8206
Email
morristillmanje@upmc.ed
First Name & Middle Initial & Last Name & Degree
Mary L Phillips, MD, MD
First Name & Middle Initial & Last Name & Degree
Fabio Ferrarelli, MD, PhD
First Name & Middle Initial & Last Name & Degree
Khaled Moussawi, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Informed consent will be collected from study participants that allows for broad sharing of participants' de-identified data. Data transfer procedures will be in accordance with all Institutional Review Board guidelines and federal regulations including HIPAA (Health Insurance Portability and Accountability Act of 1996).
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry
We'll reach out to this number within 24 hrs