NCT07250828
Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy
Enrolling by Invitation
NAAges 19+InterventionalTreatmentTriCity Research Center
~20 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:BurstDR Spinal Cord Stimulation
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
VAS Change Baseline to 6 Month
Measured over 1 month, 3 months, and 6 months
Conditions
Where it's being run
1 sites across 1 statesNebraska1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- VAS Change Baseline to 6 Month1 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.