Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy
- NCT ID
- NCT06287736
- Registry status
- Recruiting
- Study type
- Not specified in the registry data
- Phase
- Not applicable
- Sponsor
- Ohio State University
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 60 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following eligibility 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
Study locations
1 study location is listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: United States
- Ohio, United States: 1
Sample of listed locations
- The Ohio State University Wexner Medical Center — Columbus, Ohio, 43210, United States — Site recruitment status not specified in the registry data
Study details
- Start date
- April 17, 2024
- Primary completion date
- February 1, 2028
- First posted
- March 1, 2024
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT06287736
- Registry last updated
- July 23, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT06287736 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
About joining clinical research
Find clinical trials you may match with
QualifiedStudies can help you search for research opportunities related to your health. Availability of this specific study through QualifiedStudies has not been established.
Find clinical trials you may match with | Diabetic Neuropathy studies | Clinical trial FAQ