Using spinal cord stimulation to treat diabetic peripheral neuropathy
A Novel Neuromodulation Approach to Target Small Fiber Neuropathy Early in Diabetes and Measure Functional Recovery
This study is testing if spinal cord stimulation can help people with diabetic peripheral neuropathy feel less pain and improve their nerve health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06287736 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective randomized control trial that aims to evaluate the effectiveness of spinal cord stimulation (SCS) in treating diabetic peripheral neuropathy (DPN). Participants will be randomly assigned to one of three groups: two treatment groups receiving SCS and one control group. The study will measure pain levels, DPN severity, small fiber nerve activity, and metabolic health markers before and after the SCS treatment. The goal is to gather more information on the diagnosis and treatment of DPN using SCS.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with diabetic peripheral neuropathy that has not responded to standard treatments.
Not a fit: Patients with severe medical comorbidities or those who cannot undergo surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from diabetic peripheral neuropathy.
How similar studies have performed: Previous studies have shown that spinal cord stimulation can be effective in treating chronic pain, including diabetic peripheral neuropathy, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Columbus, Ohio
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Brian Dalm, MD — Ohio State University
- Study coordinator: Alexander Price
- Email: Alexander.Price2@osumc.edu
- Phone: 614-366-7822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.