Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06000592
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2023-06-23
Brief Title:
Safety Feasibility and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI
Sponsor:
Jill M Wecht EdD
Organization:
James J Peters Veterans Affairs Medical Center
Study Overview
Official Title:
Safety Feasibility and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension OH remain inadequate during acute inpatient rehabilitation AIR following a traumatic spinal cord injury SCI A critical need exists for the identification of safe practical and effective treatment options that stabilize blood pressure BP after traumatic SCI Recent published evidence suggests that transcutaneous Spinal Cord Stimulation TSCS can be used to raise seated BP and mitigate the falls in BP during orthostatic repositioning in individuals with chronic SCI This site-specific project will focus on the use of TSCS to stabilizing seated BP and mitigate the fall in BP during orthostatic repositioning during AIR following traumatic SCI
Detailed Description:
Based on available evidence TSCS may have advantages over current pharmacological approaches to the treatment of hypotension and OH 1 does not exacerbate polypharmacy 2 can be activateddeactivated rapidly and 3 can be applied in synergy with physical exercise TSCS represents an alternate approach to epidural SCS with far greater potential to reach large numbers of individuals thus providing for a greater likelihood of clinical implementation with fewer risk We are asking several key questions 1 what are the effects of TSCS on seated BP and BP changes during an orthostatic challenge 2 is the application of TSCS during AIR tolerable based on pain reporting 3 is there evidence of superficial burns to the skin near the site of cathode or anode placement and 4 are the symptoms of orthostatic intolerance reduced with TSCS To facilitate adoption of TSCS for widespread clinical use we have designed a spatial-temporal mapping and parameter configuration approach that will result in a key deliverable for SCI care a standard easy to follow algorithm that will maximize individual benefits of spinal neuromodulation while minimizing the burden on healthcare professionals This project will provide the foundational evidence to support the feasible and safe application of TSCS for widespread clinical utility in the newly injured SCI population thereby overcoming barriers to engagement in prescribed AIR regimens that are imposed by autonomic nervous system dysfunction
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?:
None
Is an FDA AA801 Violation?:
None