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A Novel Neuromodulation Approach to Target Small Fiber Neuropathy Early in Diabetes and Measure Functional Recovery
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Start Date
April 17, 2024
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2027
Last Updated
July 22, 2025
60
ESTIMATED participants
Spinal Cord Stimulator Implantation (SCS)
DEVICE
Lead Sponsor
Ohio State University
Collaborators
NCT07274735
NCT06483620
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07028528