Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

NCT06287736 | Recruiting FDA Device

• 2 other identifiers: 2023H03861R01DK138849-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• change in neuropathic symptoms using Michigan Neuropathy Screening instrument

  18 months post baseline

Study Arms (3)

Conventional Medical Management (CMM). Group1

NO INTERVENTION

Spinal Cord Stimulator (SCS) immediate activation. Group 2

ACTIVE COMPARATOR

Device: Spinal Cord Stimulator Implantation (SCS)

Spinal Cord Stimulator (SCS) Delayed activation. Group 3

ACTIVE COMPARATOR

Device: Spinal Cord Stimulator Implantation (SCS)

Interventions

Spinal Cord Stimulator Implantation (SCS) DEVICE

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

Spinal Cord Stimulator (SCS) Delayed activation. Group 3; Spinal Cord Stimulator (SCS) immediate activation. Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• Neuright, Inc.: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Study Officials

• Brian Dalm, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Price

CONTACT

614-366-7822; Alexander.Price2@osumc.edu

Uchechi Okafor

CONTACT

614.293.4876; Uchechi.Okafor@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Neurological Surgery

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 1, 2024
• Study Start: April 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

US (1)