Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy

Who can take part

• 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

Who cannot take part

• Prior spinal cord stimulator implantation or previous SCS trial that was unsuccessful
• 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 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
• Any condition that, in the investigator's opinion, makes the participant unsuitable for SCS therapy or the study
• Uncontrolled diabetes (e.g., HbA1c > 10%)
• Contraindications to SCS placement, including:
• Severe renal or hepatic dysfunction
• 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