Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05598931
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2021-06-16
Brief Title:
Development of Neuro-Navigated Transcranial Magnetic Stimulation TMS Using MRI
Sponsor:
Soterix Medical
Organization:
Soterix Medical
Study Overview
Official Title:
Development of Neuro-Navigated Transcranial Magnetic Stimulation TMS Using MRI
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Healthy controls HC will be studied once to provide data needed to validate the virtual neuro-navigation system All subjects will undergo a single MRI session and will then participate in an on-line neuro-navigation session in which various TMS coil positions will be recorded The brainhead images will be provided to the programmer to permit development of the virtual neuro-navigation algorithm Data from Yr1 will be used by the programmer as a training sample and from Yr2 as a test sample
Detailed Description:
HC subjects n10yr will be studied once to provide data needed to validate the virtual neuro-navigation system All subjects will undergo a single Human Connectome Project compatible MRI session permitting application of both surface-based and more standard volumetric analyses Subjects will then participate in an on-line neuro-navigation session in which TMS coil positions in 1020 coordinate space will be recorded corresponding to the following targets 1 hand-representation of motor strip 2 5-cm location 3 55 cm location 4 MNI coordinates corresponding to the Fitzgerald4 and Weigand6 volumetric targets 5 peak anti-correlated region calculated from rsfcfMRI data alone 6 center of our targeted parcel calculated using surface-based approaches The brainhead images will be provided to the programmer to permit development of the virtual neuro-navigation algorithm Data from Yr1 will be used by the programmer as a training sample and from Yr2 as a test sample The GoNo-go criterion is an interclass correlation coefficient ICC of 9 between scalp coordinates determined by on-line neuro-navigation and those determined virtually
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?:
False
Is an FDA AA801 Violation?:
None