Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

Last updated: July 17, 2024
Sponsor: Ohio State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Diabetic Neuropathy

Neurologic Disorders

Treatment

Spinal Cord Stimulator Implantation (SCS)

Clinical Study ID

NCT06287736
2023H0386
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Over 18 years old

  • Diagnosis of diabetic peripheral neuropathy refractory to treatment with gabapentinor 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

Exclusion Criteria:

  • Severe medical comorbidities that, in the opinion of the surgeon, exclude thepatient from surgical intervention

  • Spinal disease with severe spinal stenosis or spinal cord compression in the regionof 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 Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Spinal Cord Stimulator Implantation (SCS)
Phase:
Study Start date:
April 17, 2024
Estimated Completion Date:
December 31, 2026

Study Description

Peripheral neuropathy (PN) is caused by diabetes, aging, chemotherapy, and over 30 other conditions, and impacts more than 30 million patients in the US alone. Diabetes is the number one cause of peripheral neuropathy, and more than half of patients with diabetes will eventually develop diabetic peripheral neuropathy (DPN), a complex set of symptoms including pain, numbness, tingling, and burning. Spinal cord stimulation (SCS) is an approved intervention for the treatment of chronic pain, including DPN. Spinal cord stimulation has had FDA approval for the treatment of painful DPN since 2015. This study is being done to learn more about the diagnosis of DPN and treatment of DPN with SCS.

Connect with a study center

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

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