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Taking people in United StatesNo phase

Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

Key facts

Who runs it
Ohio State University
Where
Columbus, United StatesSee the site
Trial code
Status
Recruiting
People taking part
60 people, planned
Started
17 Apr 2024
Expected to end
3 Jul 2028
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Spinal Cord Stimulator Implantation (SCS)
Record updated
23 July 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Severe medical comorbidities that, in the opinion of the surgeon, exclude the patient from surgical intervention
  • Unable to discontinue blood thinning medications
  • Spinal disease with severe spinal stenosis or spinal cord compression in the region of the proposed spinal cord stimulator lead placement
  • Presence of systemic infection
  • Hemoglobin A1c level greater than 10
  • Coagulopathy that cannot be corrected
  • Pregnancy

Where in United States

  • The Ohio State University -Wexner Medical CenterColumbus, United StatesContact: Aladdin AlqaisiTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Conventional Medical Management (CMM). Group1No study treatment, for comparison
  • Spinal Cord Stimulator (SCS) immediate activation. Group 2Existing treatment, for comparison

    Treatment: Spinal Cord Stimulator Implantation (SCS)

  • Spinal Cord Stimulator (SCS) Delayed activation. Group 3Existing treatment, for comparison

    Treatment: Spinal Cord Stimulator Implantation (SCS)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Novel Neuromodulation Approach to Target Small Fiber Neuropathy Early in Diabetes and Measure Functional Recovery
Record updated
23 July 2026