Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05792020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-03-17
Brief Title:
Safety Parameterization and Mechanism of Transcranial Focused Ultrasound
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Safety Parameterization and Mechanism of Transcranial Focused Ultrasound fUS Over the Motor Cortex
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Through the BrainBox Initiative investigators propose to study the effects of motor tFUS on Motor Evoked Potentials MEPs and GABA and Glutamate Concentrations in the Brain
Detailed Description:
tFUS is an emerging neuromodulatory tool that uses pulses of low-intensity acoustic waves to stimulate deep brain structures such as the thalamus tFUS has recently been used to probe deep brain structures in unresponsive wakefulness pain anxiety and other neuropsychiatric conditions However tFUS is restricted mainly by use in the MR scanner environment thus limiting session numbers by scan cost and participant comfort Furthermore with few human studies to date the parameter space and mechanisms of action warrant further elucidation Using novel focused ultrasound methods investigators can stimulate at a minimum penetration distance of 20mm uniquely enabling the study of the neuromodulatory effects of tFUS on cortical tissue Specifically investigators propose to study the effects of motor tFUS on motor-evoked potentials MEPs and GABA concentration The proposed research is critical for understanding tFUS and advancing its therapeutic potential for future clinical trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None