Home › NCT06287736

Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

A Novel Neuromodulation Approach to Target Small Fiber Neuropathy Early in Diabetes and Measure Functional Recovery

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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 ≥4 on a visual analog scale
* DN4 ≥4
* Pass pre-operative neuropsychological assessment (surgical group only)
* Capable of providing informed consent

Exclusion Criteria:

* 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

About the study

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.

What is being tested

• Spinal Cord Stimulator Implantation (SCS) (device)

Sponsor: Ohio State University · Participants: 60 · Started: Apr 17, 2024

Contact the study team

• Alexander Price · Phone: 614-366-7822

Official record on ClinicalTrials.gov — NCT06287736

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.