Impulsive BehaviorNCT05875181
Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry
A study testing tFUS in people with Impulsive Behavior, run by Mary Phillips, MD MD (Cantab) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Impulsive Behavior
- What is being tested?
- tFUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years of age
- No psychiatric history
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Impulsive Behavior
- Being tested
- tFUS, Sham tFUS
- Keywords
- transcranial focused ultrasound, Magnetic Resonance Imaging
- Medical subject headings
- Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tFUSDevice
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 tFUSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Device: tFUS; Device: Sham tFUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygen level-dependent (BOLD) signal
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Measured: 30-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start19 Jun 2023
- Primary completion1 Dec 2024
- Study completionDec 2024 (estimated)
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impulsive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Phillips, MD MD (Cantab)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mary Phillips, MD MD (Cantab), University of Pittsburgh
- Investigators
- Mary Phillips, MD, MD, Principal investigator, University of PittsburghFabio Ferrarelli, MD, PhD, Principal investigator, University of PittsburghKhaled Moussawi, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875181
- Sponsor's protocol ID
- STUDY23020148
- Status last verified
- Dec 2024
- First submitted
- 24 Apr 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry
- ClinicalTrials.gov ID
- NCT05875181
- Acronym / sponsor ID
- STUDY23020148
- Conditions
- Impulsive Behavior
- Keywords
- transcranial focused ultrasound, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mary Phillips, MD MD (Cantab)University, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VS tFUS/Sham tFUS | Experimental | Device: tFUS, Device: Sham tFUSVS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS) |
| Sham tFUS/VS tFUS | Experimental | Device: tFUS, Device: Sham tFUSVS tFUS (tFUS applied to the ventral striatum) Sham tFUS (go through the motions of applying tFUS to the VS) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-35 years of age
- No psychiatric history
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tFUStFUS 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/VS tFUS, VS tFUS/Sham tFUS |
| Sham tFUSSham 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 | Device | Sham tFUS/VS tFUS, VS tFUS/Sham tFUS |
Primary outcome
Blood oxygen level-dependent (BOLD) signal
Time frame: 30-60 minutes
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Phillips, MD, MD principal investigator
University of Pittsburgh
Fabio Ferrarelli, MD, PhD principal investigator
University of Pittsburgh
Khaled Moussawi, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tFUS in people with Impulsive Behavior, run by Mary Phillips, MD MD (Cantab) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood oxygen level-dependent (BOLD) signal (time frame: 30-60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.