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| ID | Type | Description | Link |
|---|---|---|---|
| NBRFP23 P31 | Other Grant/Funding Number | Nano-Bio Materials Consortium |
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Funding terminated prior to initiation.
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| Name | Class |
|---|---|
| Attune Neurosciences Inc | INDUSTRY |
| Nano-Bio Materials Consortium | UNKNOWN |
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The investigators goal is to target FUS energy to the centromedian nucleus of the thalamus (CMT), the core of arousal, which is inaccessible by traditional non-invasive neuromodulation devices. The CMT is an ideal stimulation target for augmenting alertness, as it is intimately linked with the cortex through the well described thalamocortical circuit to entrain network oscillations.
In this research study, the investigators will utilize a novel wearable device (ATTN201) to test the dose-response effects of FUS stimulation of the centromedian nucleus of the thalamus (CMT) on alertness, cognitive performance, and reaction time, as well as sleep EEG recordings. Unlike existing technologies, the device in this study will use offline MRI guidance, which is not needed during the actual treatment, allowing users for the first time to sleep and comfortably wear the device out of the clinic. This unique offline MRI guidance approach uses the device's precise head registration and brain anatomy to allow for customized and repeatable tFUS delivery to the CMT.
For this study, the investigators will recruit up to 36 healthy subjects for a safety study that will objectively assess brain parenchyma morphology, and neuropsychiatric and neuropsychological function, following tFUS exposure of the CMT. EEG recordings during parametric sweeps will be obtained for observation of changes in brain network activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focused Ultrasound Dose #1 | Experimental | Focused Ultrasound will be administered using high frequency stimulation as condition 1. Stimulation will last 1-10 minutes. |
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| Focused Ultrasound Dose #2 | Experimental | Focused Ultrasound will be administered using medium frequency stimulation as condition 2. Stimulation will last 1-10 minutes. |
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| Focused Ultrasound Dose #3 | Experimental | Focused Ultrasound will be administered using low frequency stimulation as condition 4. Stimulation will last 1-10 minutes. |
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| Focused Ultrasound Dose #4 | Sham Comparator | Focused Ultrasound will be administered using the sham condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Focused Ultrasound | Device | Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions |
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| Measure | Description | Time Frame |
|---|---|---|
| EEG changes pre- to post-FUS | Frequency band analysis of EEG data | 2 years |
| Reaction time on Psychomotor vigilance task | Measuring reaction time on PVT pre- to post-FUS | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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Each participant receives 4 stimulation conditions in a counterbalanced order across 4 visits (1 stimulation condition/visit)
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Double-blind sham-controlled
| Transcranial Focused Ultrasound | Device | Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions |
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| Transcranial Focused Ultrasound | Device | Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions |
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| Transcranial Focused Ultrasound | Device | Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions |
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