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NCT Number: NCT06287736

Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

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.

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Key information

Conditions

Diabetic Peripheral Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Aladdin Alqaisi

CONTACT

[email protected]

380-283-6363

Bakri Elsheikh, MD

SUB_INVESTIGATOR

Brian Dalm, MD

PRINCIPAL_INVESTIGATOR

Kristy Townsend, PhD

SUB_INVESTIGATOR

Magdalena Blaszkiewicz, PhD

SUB_INVESTIGATOR

Miriam Freimer, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in Pain level

    Time frame: 18 months post baseline

    change in Visual analog pain scale (VAS). The VAS endpoints range from 'no pain at all' to 'pain as bad as it could be'

  2. Change in Diabetic Peripheral Neuropathy (DPN) Pain using the Neuropathic pain diagnostic questionnaire (DN4)

    Time frame: 18 months post baseline

    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

  3. Change in PROMIS quality of life in relation to pain level

    Time frame: 18 months post baseline

    Change in patient-reported outcomes measurement (PROMIS 29)

Secondary outcomes

  1. change in neuropathic symptoms using Michigan Neuropathy Screening instrument

    Time frame: 18 months post baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Price

CONTACT

[email protected]

614-366-7822

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Neuright, Inc.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 1, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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