BurstDR Spinal Cord Stimulation for Diabetic Neuropathy

(ABBT DPN Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TriCity Research Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This prospective, single-arm clinical study evaluates the therapeutic efficacy and feasibility of BurstDR spinal cord stimulation (SCS) using Abbott's Proclaim XR and Eterna systems in patients with painful diabetic neuropathy (PDN). Adults with confirmed PDN will undergo a one-week temporary SCS trial, and those achieving meaningful improvement (≥50% reduction in average pain on the Visual Analog Scale) will proceed to permanent implantation. Outcomes will be assessed at baseline, end of trial, and at 1-, 3-, and 6-month follow-up visits using validated instruments including VAS, DN4, DQoL, PSQ-3, the Patient Global Impression of Change, and the Clinician Global Impression of Change. All procedures follow standard clinical practice for SCS therapy. The study aims to characterize real-world effectiveness, patient-reported outcomes, feasibility of implementation, and device-related safety in a rural PDN population.

Are You a Good Fit for This Trial?

This clinical trial is for adults with painful diabetic neuropathy (PDN) who have not found relief from other treatments. Participants must show a significant reduction in pain during a one-week test to qualify for permanent treatment.

Inclusion Criteria

DN4 score ≥4, indicating neuropathic pain characteristics

Able and willing to comply with all trial procedures and follow-up visits

Able to provide written informed consent in English or in an IRB-approved translated language

Exclusion Criteria

Contraindications to SCS placement, including active systemic infection or local infection at planned needle entry site, bleeding disorders or inability to temporarily discontinue anticoagulation if required, known allergy to device materials or components

Prior spinal cord stimulator implantation or previous SCS trial that was unsuccessful

Severe or uncontrolled psychiatric illness that, in the investigator's judgment, may interfere with study compliance

What Are the Treatments Tested in This Trial?

Interventions

• BurstDR Spinal Cord Stimulation

Trial Overview The study tests the effectiveness of BurstDR Spinal Cord Stimulation using Abbott's systems on PDN. Patients will be evaluated over six months to see if this therapy can consistently reduce their pain and improve quality of life.

How Is the Trial Designed?

Group I: Test Group [Burst DR SCS] Experimental Treatment 1 Intervention

Participants receive BurstDR spinal cord stimulation delivered through Abbott Proclaim XR or Eterna systems, beginning with a temporary trial followed by permanent implantation for responders.

Who Is Running the Clinical Trial?

TriCity Research Center

Lead Sponsor

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business