Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

Description

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

Diabetic Peripheral Neuropathy

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Study Overview

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Study Details

Study overview

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.

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

Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

Condition
Diabetic Peripheral Neuropathy
Intervention / Treatment

-

Contacts and Locations

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ohio State University,

Brian Dalm, MD, PRINCIPAL_INVESTIGATOR, The Ohio State University Wexner Medical Center

Study Record Dates

2026-12-31