Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy

NCT07250828 · tracked via the Priya Life Science USA tracker

Sponsor

TriCity Research Center

Phase

Not applicable

Started

2025-12-15

Last updated

2026-05-08

Condition(s) studied

Painful Diabetic Neuropathy (PDN)Diabetic NeuropathyNeuropathic PainChronic Pain

Investigational drug(s) / intervention(s)

BurstDR Spinal Cord Stimulation

BurstDR Spinal Cord Stimulation: 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 summary

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.

Eligibility

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age 19 years or older. * Diagnosis of diabetic peripheral neuropathy (DPN) confirmed by nerve conduction study (EMG/NCS) or skin biopsy. * Persistent neuropathic pain in the lower extremities for ≥6 months. * Average baseline pain score of ≥6 on the Visual Analog Scale (VAS). * DN4 score ≥4, indicating neuropathic pain characteristics. * Inadequate pain relief with conventional medical therapy, including at least two classes of analgesic or neuropathic pain medications (e.g., gabapentinoids, SNRIs, TCAs, opioids). * Candidate for spinal cord stimulation based on clinical evaluation by the treating physician. * 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: * Prior spinal cord stimulator implantation or previous SCS trial that was unsuccessful. * 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 * Severe uncontrolled medical conditions that increase surgical risk, including: * Unstable cardiovascular disease * Severe renal or hepatic dysfunction * Uncontrolled diabetes (e.g., HbA1c \> 10%) * Severe or uncontrolled psychiatric illness that, in the investigator's judgment, may interfere with study compliance. * Current substance use disorder, including active opioid misuse or illicit drug use, based on clinician assessment. * Pregnancy or planning to become pregnant during the study period. * Life expectancy less than 12 months. * Participation in another interventional clinical trial that may confound results or interfere with study procedures. * Any condition that, in the investigator's opinion, makes the participant unsuitable for SCS therapy or the study.

Primary outcome measure(s)

VAS Change Baseline to 6 Month — 1 month, 3 months, and 6 months
Pain will be assessed using the Visual Analog Scale (VAS). The primary endpoint is the proportion of participants who achieve at least a 50% reduction in average VAS pain score from baseline to each follow-up visit after permanent implantation.

Trial sites (1)

Facility	City	Region	Status
Grand Island Pain Relief Center	Grand Island	Nebraska

More TriCity Research Center trials in the USA

Pilot Study to Evaluate Changes in Intra-Epidermal Nerve Fiber Density (IENFD) in Patients With Small-Fiber Neuropathy Enrolling by invitation

Medtronic Inceptiv™ Closed-Loop DTM Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy Enrolling by invitation

Other trials for the same condition

Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator Recruiting

Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy Recruiting

Virtual Reality Treatment for Adults With Chronic Back Pain (VRNT) Active, not recruiting

HFIT Versus TENS Study for Chronic Low Back and Knee Pain Active, not recruiting

Focused Ultrasound Stimulation for the Treatment of Chronic Pain Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07250828 on ClinicalTrials.gov ↗ ← All trials in the USA