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The data from this pilot study was intended to generate effect sizes and pilot data for a subsequent grant application. However, the grant application was awarded funding before this pilot study collected data.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood oxygen level-dependent (BOLD) signal | The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity | 30-60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
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).
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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.
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.
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| ID | Term |
|---|---|
| D007175 | Impulsive Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| 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 |
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