Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410001
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-04-19
Brief Title:
CE-STAND Cervical Epidural STimulation After Neurologic Damage
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
CE-STAND Cervical Epidural STimulation After Neurologic Damage
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:
Research on chronic cervical injuries is under-represented There are very few studies in this arena and none that utilize gold-standard techniques to measure sympathetic activity This proposal aims to address all three of these highlighted areas cervical chronic and autonomic dysfunction and thus is both significant and highly impactful as treating autonomic dysfunction could substantially improve function and quality of life QoL in chronic cervical SCI patients Further we will use microneurography a novel technique to measure muscle sympathetic nerve activity MSNA to quantify autonomic function in cervical SCI
The spinal cord stimulator system Abbott Eterna system implantable pulse generator IPG charger and TriCentrus lead will be used for this study which is manufactured by Abbott Laboratories The stimulators are commercially marketed and they are Food and Drug Administration FDA approved for use in chronic intractable pain of the trunk andor limbs including unilateral or bilateral pain associated with failed back surgery syndrome and intractable low back and leg pain While they can be used in SCI patients who suffer from any of these above-mentioned things they are not approved for restoration of voluntary movement andor autonomic dysfunction Therefore The CE-STAND study is a treatment based investigation Because it is exploring both safety and efficacy it is classified as a Phase III study and thus it is not expected to support a marketing application The study model is a single group with eSCS on as the intervention and eSCS off as the control with participants acting as their own controls
The spinal cord stimulator system Abbott Eterna system implantable pulse generator IPG charger and TriCentrus lead will be used for this study which is manufactured by Abbott Laboratories The stimulators are commercially marketed and they are Food and Drug Administration FDA approved for use in chronic intractable pain of the trunk andor limbs including unilateral or bilateral pain associated with failed back surgery syndrome and intractable low back and leg pain While they can be used in SCI patients who suffer from any of these above-mentioned things they are not approved for restoration of voluntary movement andor autonomic dysfunction Therefore The CE-STAND study is a treatment based investigation Because it is exploring both safety and efficacy it is classified as a Phase III study and thus it is not expected to support a marketing application The study model is a single group with eSCS on as the intervention and eSCS off as the control with participants acting as their own controls
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None