NCT06287736 Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy
| NCT ID | NCT06287736 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Diabetic Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-04-17 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-04-17 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Brian Dalm, MD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT06287736 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06287736 currently recruiting?
Yes, NCT06287736 is actively recruiting participants. Contact the research team at Alexander.Price2@osumc.edu for enrollment information.
Where is the NCT06287736 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT06287736 clinical trial?
NCT06287736 is sponsored by Ohio State University. The principal investigator is Brian Dalm, MD at Ohio State University. The trial plans to enroll 60 participants.