Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy (NCT07250828) | Clinical Trial Compass
By InvitationNot Applicable
Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy
United States20 participantsStarted 2025-12-15
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 compli…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.