CE-STAND: Cervical Epidural STimulation After Neurologic Damage

Status Not yet recruiting

Clinical Trial 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 and/or 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 and/or 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 I/II 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06410001
Study type	Interventional
Source	University of Minnesota
Contact	Nadine Mansour
Email	nmansour@umn.edu
Status	Not yet recruiting
Phase	Phase 1/Phase 2
Start date	June 1, 2024
Completion date	June 1, 2028

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See also
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