Actively Recruiting
Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy
Led by Ohio State University · Updated on 2025-07-22
60
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
N
Neuright, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years old
- Diagnosis of diabetic peripheral neuropathy refractory to treatment with gabapentin or pregabalin and at least 1 other class of analgesic
- Diagnosis of medically refractory pain secondary to diabetic neuropathy
- Presence of pain for 12 months
- Lower limb pain intensity score 64 on a visual analog scale
- DN4 64
- Pass pre-operative neuropsychological assessment (surgical group only)
- Capable of providing informed consent
You will not qualify if you...
- Severe medical comorbidities that, in the opinion of the surgeon, exclude the patient from surgical intervention
- Spinal disease with severe spinal stenosis or spinal cord compression in the region of the proposed spinal cord stimulator lead placement
- Coagulopathy that cannot be corrected
- Unable to discontinue blood thinning medications
- Hemoglobin A1c level greater than 10
- Presence of systemic infection
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
A
Alexander Price
CONTACT
U
Uchechi Okafor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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