Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy
A Novel Neuromodulation Approach to Target Small Fiber Neuropathy Early in Diabetes and Measure Functional Recovery
Ohio State University
60 participants
Apr 17, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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 Criteria7
- 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
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Interventions
Spinal cord stimulator implantation is broken up into two parts. The first part involves placement of temporary SCS leads for a one-week trial. If the participants respond favorably to the SCS, then they will undergo the second part and the device is implanted
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06287736