Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy

Part of paid clinical trials in Grand Island, Nebraska.

Sponsor
TriCity Research Center
Study ID
NCT07250828
Status
Enrolling By Invitation

Conditions

  • Chronic Pain
  • Diabetic Neuropathy
  • Neuropathic Pain
  • Painful Diabetic Neuropathy (PDN)

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BurstDR Spinal Cord Stimulation — DEVICE
    Participants receive BurstDR spinal cord stimulation delivered through Abbott Proclaim XR or Eterna spinal cord stimulator systems in a standard of care routine. The intervention includes a one-week temporary SCS trial using percutaneous leads, followed by permanent implantation of the Proclaim XR or Eterna implantable pulse generator for participants who experience meaningful pain relief during the trial. Device programming and follow-up assessments follow standard clinical practice.

Study Details

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.

Key Dates

Start date
Dec 15, 2025
Status verified
Nov 2025
Primary completion
Jan 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Test Group [Burst DR SCS]
    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.

Primary Outcome Measure

VAS Change Baseline to 6 Month [ Time Frame: 1 month, 3 months, and 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Grand Island Pain Relief CenterGrand IslandNebraska68803-

Find similar trials in Grand Island, NE

By research site
Grand Island Pain Relief Center· Grand Island, NE

Related Studies