Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

A Novel Neuromodulation Approach to Target Small Fiber Neuropathy Early in Diabetes and Measure Functional Recovery

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Device: Spinal Cord Stimulator Implantation (SCS)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Uchechi Okafor; Phone Number: 614.293.4876; Email: Uchechi.Okafor@osumc.edu
• Study Contact Backup: Name: Alexander Price; Phone Number: 614-366-7822; Email: Alexander.Price2@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Principal Investigator: Brian Dalm, MD
      • Sub-Investigator: Kristy Townsend, PhD
      • Sub-Investigator: Magdalena Blaszkiewicz, PhD
      • Sub-Investigator: Miriam Freimer, MD
      • Sub-Investigator: Bakri Elsheikh, MD
      • Contact: Uchechi Okafor; Phone Number: 614-293-4876; Email: Uchechi.Okafor@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional Medical Management (CMM). Group1
Active Comparator: Spinal Cord Stimulator (SCS) immediate activation. Group 2	Device: Spinal Cord Stimulator Implantation (SCS); 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
Active Comparator: Spinal Cord Stimulator (SCS) Delayed activation. Group 3	Device: Spinal Cord Stimulator Implantation (SCS); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain level	change in Visual analog pain scale (VAS). The VAS endpoints range from 'no pain at all' to 'pain as bad as it could be'	18 months post baseline
Change in Diabetic Peripheral Neuropathy (DPN) Pain using the Neuropathic pain diagnostic questionnaire (DN4)	Neuropathic Pain Diagnostic "Douleur Neuropathique 4" questionnaire (DN4) is a screening questionnaire to help identify neuropathic pain (NP) in clinical practice and research. It is a clinican-administered questionnaire consisting of 10 items.The first 7 symptoms items are scored by interviewing the patient, and the 3 remaining items are scored by means of clinical examination. The scores are added and a score of 4 or more out of 10 is suggestive of neuropathic pain	18 months post baseline
Change in PROMIS quality of life in relation to pain level	Change in patient-reported outcomes measurement (PROMIS 29)	18 months post baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in neuropathic symptoms using Michigan Neuropathy Screening instrument	change in Michigan Neuropathy Screening instrument (MNSI). The MNSI is designed to be used in the outpatient setting. The MNSI is broken up into 2 parts. The first part consists of 15 yes/no questions on foot sensation. The highest score is 13, and the higher the score indicates more neuropathic symptoms.	18 months post baseline

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Neuright, Inc.
• Investigators: Principal Investigator: Brian Dalm, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 2023H0386; 1R01DK138849-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No