Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy
Enrolling by invitation · Not applicable
Conditions studied: Painful Diabetic Neuropathy (PDN), Diabetic Neuropathy, Neuropathic Pain, Chronic Pain
In brief
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 facts
- Study ID
- NCT07250828
- Run by
- TriCity Research Center
- People needed
- 20
- Starts
- 2025-12-15
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Grand Island Pain Relief Center — Grand Island, Nebraska, United States
Full record on ClinicalTrials.gov
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