Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287736
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-13
Brief Title:
Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
A Novel Neuromodulation Approach to Target Small Fiber Neuropathy Early in Diabetes and Measure Functional Recovery
Status:
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:
This is a prospective randomized control trial Participants enrolled into the study will be randomized into one of three groups two of which are treatment groups and the third is a control group A time course of measurements before and after spinal cord stimulation SCS treatment where applicable will assess pain DPN severity small fiber nerve activity and metabolic health markers
Detailed Description:
Peripheral neuropathy PN is caused by diabetes aging chemotherapy and over 30 other conditions and impacts more than 30 million patients in the US alone Diabetes is the number one cause of peripheral neuropathy and more than half of patients with diabetes will eventually develop diabetic peripheral neuropathy DPN a complex set of symptoms including pain numbness tingling and burning Spinal cord stimulation SCS is an approved intervention for the treatment of chronic pain including DPN Spinal cord stimulation has had FDA approval for the treatment of painful DPN since 2015 This study is being done to learn more about the diagnosis of DPN and treatment of DPN with SCS
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