Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461221
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-04-19
Brief Title:
tFUS to Enhance Alertness and Performance
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Individualized Focused Ultrasound Stimulation of the Brain to Enhance Alertness and Cognitive Performance
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 devices 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None