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Aim: Evaluate whether sonicating the Nucleus Accumbens (NAc) with transcranial focused ultrasound modifies functional connectivity between the NAc and the prefrontal cortex (PFC).
In this single visit, open-label pilot trial, we plan to evaluate whether transcranial focused ultrasound (tFUS), delivered to the nucleus accumbens (NAc) within the magnetic resonance imaging (MRI) scanner will impact resting state functional connectivity between the NAc and functionally connected brain regions like the prefrontal cortex (PFC) and the anterior cingulate cortex (ACC) in up to 10 healthy individuals.
HYPOTHESIS : tFUS will reduce prefrontal cortex (PFC)-NAc functional connectivity, in healthy individuals. We will investigate this hypothesis by administering tFUS within to MRI scanner to healthy individuals and conduct resting state functional neuroimaging before- and after the tFUS stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tFUS | Experimental | tFUS will be administered within the MRI scanner. Participants receive two, 10-min sessions of active tFUS spread 10 min apart targeting the nucleus accumbens. |
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| Sham tFUS | Sham Comparator | No ultrasound will be delivered to the participant during the experiment. Participants will not know or be told whether they are receiving active- or sham- tFUS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial focused ultrasound (tFUS) | Device | Transcranial focused ultrasound (tFUS) is a promising new technology that is both noninvasive and may be focally applied to deep brain targets. tFUS utilizes transducers which contain piezoelectric elements to produce pulses of ultrasonic waves that summate deep in the brain. Transcranial focused ultrasound (tFUS) uses a single transducer fixed in a head-worn apparatus on the scalp to produce ultrasonic waves deep into the brain. |
| Measure | Description | Time Frame |
|---|---|---|
| Resting State Functional Connectivity | The main outcomes of this study are brain imaging related. Using a neuroimaging technique called resting state functional connectivity, which is a statistical dependence between time series of electro-physiological activity and (de)oxygenated blood levels in distinct regions of the brain. Modularity is measured on a -1 to 1 scale, with higher scores indicating stronger community structure, or a stronger tendency of clusters of brain regions to separate into distinct, highly interconnected networks with sparse connections across networks. The optimal modularity value depends on the context. For example, during complex tasks lower modularity is better, while during basic, automatic tasks higher modularity is better. | 24 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina Institute of Psychiatry | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tFUS | tFUS will be administered within the MRI scanner. Participants receive two, 10-min sessions of active tFUS spread 10 min apart targeting the nucleus accumbens. transcranial focused ultrasound (tFUS): Transcranial focused ultrasound (tFUS) is a promising new technology that is both noninvasive and may be focally applied to deep brain targets. tFUS utilizes transducers which contain piezoelectric elements to produce pulses of ultrasonic waves that summate deep in the brain. Transcranial focused ultrasound (tFUS) uses a single transducer fixed in a head-worn apparatus on the scalp to produce ultrasonic waves deep into the brain. |
| FG001 | Sham tFUS | The sham sessions will include a transducer that is connected in a similar fashion to that of active tFUS, however the cable will not be plugged into the system, thus no ultrasound will be delivered to the participant. Participants will not know or be told whether they are receiving active- or sham- tFUS. transcranial focused ultrasound (tFUS): Transcranial focused ultrasound (tFUS) is a promising new technology that is both noninvasive and may be focally applied to deep brain targets. tFUS utilizes transducers which contain piezoelectric elements to produce pulses of ultrasonic waves that summate deep in the brain. Transcranial focused ultrasound (tFUS) uses a single transducer fixed in a head-worn apparatus on the scalp to produce ultrasonic waves deep into the brain. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tFUS | tFUS will be administered within the MRI scanner. Participants receive two, 10-min sessions of active tFUS spread 10 min apart targeting the nucleus accumbens. transcranial focused ultrasound (tFUS): Transcranial focused ultrasound (tFUS) is a promising new technology that is both noninvasive and may be focally applied to deep brain targets. tFUS utilizes transducers which contain piezoelectric elements to produce pulses of ultrasonic waves that summate deep in the brain. Transcranial focused ultrasound (tFUS) uses a single transducer fixed in a head-worn apparatus on the scalp to produce ultrasonic waves deep into the brain. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Resting State Functional Connectivity | The main outcomes of this study are brain imaging related. Using a neuroimaging technique called resting state functional connectivity, which is a statistical dependence between time series of electro-physiological activity and (de)oxygenated blood levels in distinct regions of the brain. Modularity is measured on a -1 to 1 scale, with higher scores indicating stronger community structure, or a stronger tendency of clusters of brain regions to separate into distinct, highly interconnected networks with sparse connections across networks. The optimal modularity value depends on the context. For example, during complex tasks lower modularity is better, while during basic, automatic tasks higher modularity is better. | Posted | Mean | Standard Error | z value | 24 minutes |
|
2 months
This study enrolled 10 participants by the end of the study, among which 5 participants received active tFUS and the other 5 participants received sham tFUS. 0 out of 5 participants in the active group and 0 out of 5 participants in the sham group were reported to have any adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active tFUS | tFUS will be administered within the MRI scanner. Participants receive two, 10-min sessions of active tFUS spread 10 min apart targeting the nucleus accumbens. transcranial focused ultrasound (tFUS): Transcranial focused ultrasound (tFUS) is a promising new technology that is both noninvasive and may be focally applied to deep brain targets. tFUS utilizes transducers which contain piezoelectric elements to produce pulses of ultrasonic waves that summate deep in the brain. Transcranial focused ultrasound (tFUS) uses a single transducer fixed in a head-worn apparatus on the scalp to produce ultrasonic waves deep into the brain. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bashar Badran | Medical University of South Carolina | 843-792-6076 | badran@musc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 29, 2023 | Jul 11, 2024 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 21, 2023 | Jul 2, 2024 | ICF_000.pdf |
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Active or Sham tFUS
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Single-blind
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| BG001 | Sham tFUS | The sham sessions will include a transducer that is connected in a similar fashion to that of active tFUS, however the cable will not be plugged into the system, thus no ultrasound will be delivered to the participant. Participants will not know or be told whether they are receiving active- or sham- tFUS. transcranial focused ultrasound (tFUS): Transcranial focused ultrasound (tFUS) is a promising new technology that is both noninvasive and may be focally applied to deep brain targets. tFUS utilizes transducers which contain piezoelectric elements to produce pulses of ultrasonic waves that summate deep in the brain. Transcranial focused ultrasound (tFUS) uses a single transducer fixed in a head-worn apparatus on the scalp to produce ultrasonic waves deep into the brain. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Healthy Individuals | Count of Participants | Participants |
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| OG001 | Sham tFUS | The sham sessions will include a transducer that is connected in a similar fashion to that of active tFUS, however the cable will not be plugged into the system, thus no ultrasound will be delivered to the participant. Participants will not know or be told whether they are receiving active- or sham- tFUS. transcranial focused ultrasound (tFUS): Transcranial focused ultrasound (tFUS) is a promising new technology that is both noninvasive and may be focally applied to deep brain targets. tFUS utilizes transducers which contain piezoelectric elements to produce pulses of ultrasonic waves that summate deep in the brain. Transcranial focused ultrasound (tFUS) uses a single transducer fixed in a head-worn apparatus on the scalp to produce ultrasonic waves deep into the brain. |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Sham tFUS | The sham sessions will include a transducer that is connected in a similar fashion to that of active tFUS, however the cable will not be plugged into the system, thus no ultrasound will be delivered to the participant. Participants will not know or be told whether they are receiving active- or sham- tFUS. transcranial focused ultrasound (tFUS): Transcranial focused ultrasound (tFUS) is a promising new technology that is both noninvasive and may be focally applied to deep brain targets. tFUS utilizes transducers which contain piezoelectric elements to produce pulses of ultrasonic waves that summate deep in the brain. Transcranial focused ultrasound (tFUS) uses a single transducer fixed in a head-worn apparatus on the scalp to produce ultrasonic waves deep into the brain. | 0 | 5 | 0 | 5 | 0 | 5 |
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