Recruiting

Spinal Cord Stimulation

Sponsor:

Ohio State University

Code:

NCT06287736

Conditions

Diabetic Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spinal Cord Stimulator Implantation (SCS)

Study Details

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

Study ID

NCT06287736

Start date

Apr 17, 2024

Status verified date

Jul, 2026

Completion date

Jul 3, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Conventional Medical Management (CMM). Group1

active comparator: Spinal Cord Stimulator (SCS) immediate activation. Group 2

active comparator: Spinal Cord Stimulator (SCS) Delayed activation. Group 3

Interventions

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

Primary outcome measure

  • Change in Pain level [ Time Frame: 18 months post baseline ]
  • Change in Diabetic Peripheral Neuropathy (DPN) Pain using the Neuropathic pain diagnostic questionnaire (DN4) [ Time Frame: 18 months post baseline ]
  • Change in PROMIS quality of life in relation to pain level [ Time Frame: 18 months post baseline ]

Central Contacts and Locations

Central contacts

Alexander Price

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

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Aladdin Alqaisi

380-283-6363aladdin.alqaisi@osumc.edu

Principal Investigator:

Brian Dalm, MD

More Information

Sponsor

Ohio State University

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-07-23.