Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy
ConditionDiabetic Peripheral Neuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Spinal Cord Stimulator Implantation (SCS)
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Ohio State University
Lead sponsor
Neuright, Inc.
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov