BurstDR Spinal Cord Stimulation for Diabetic Neuropathy

(ABBT DPN Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TriCity Research Center

Must be taking: Analgesics, Neuropathic pain meds

Disqualifiers: Uncontrolled diabetes, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BurstDR spinal cord stimulation to help people with painful diabetic neuropathy. The treatment uses special devices to send mild electrical signals to the spinal cord, aiming to reduce pain. People who have experienced neuropathic pain in their legs for at least six months and haven't found relief with other pain medications might be suitable candidates. Participants will first try the device for a week, and if they experience at least 50% less pain, a permanent device will be implanted. The trial aims to evaluate the treatment's effectiveness in real-life settings, particularly for those living in rural areas. As an unphased trial, this study offers participants the opportunity to contribute to understanding how well this treatment can improve quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have inadequate pain relief with conventional medical therapy, which suggests you might continue your current medications if they are not providing enough relief.

What prior data suggests that BurstDR spinal cord stimulation is safe for diabetic neuropathy?

Research has shown that BurstDR spinal cord stimulation (SCS) could be a good option for treating painful diabetic neuropathy (PDN). Studies have found that many patients tolerate this technology well. For instance, one study found it safe enough for the US Food and Drug Administration (FDA) to recently approve it for treating PDN.

Another study examined BurstDR SCS in people with various pain conditions, such as failed back surgery syndrome and PDN. It found that people generally handle the treatment well, with few serious side effects.

While all medical treatments have risks, the safety data for BurstDR SCS is promising. These findings suggest it's a safe option for many, but discussing personal health concerns with a doctor remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

BurstDR Spinal Cord Stimulation is unique because it offers a novel way to manage diabetic neuropathy by directly targeting the spinal cord to modulate pain signals. Unlike standard treatments such as medications or nerve blocks, BurstDR uses electrical pulses to provide targeted relief without the side effects often associated with drugs. Researchers are excited about this approach because it has the potential to offer long-term pain relief with a non-pharmacological method, particularly for those who have not responded well to traditional therapies. Additionally, this treatment begins with a temporary trial, allowing patients to experience its effects before committing to a permanent implant, which adds a layer of safety and personalization to the treatment process.

What evidence suggests that BurstDR spinal cord stimulation is effective for diabetic neuropathy?

Research has shown that BurstDR spinal cord stimulation (SCS), which participants in this trial will receive, can help people with painful diabetic neuropathy (PDN). In previous studies, individuals with PDN who used BurstDR SCS experienced significant pain relief. One study found that 83.3% of patients considered the treatment successful. Additionally, pain levels and patient-reported outcomes improved significantly after using BurstDR SCS. These results suggest that BurstDR SCS could provide meaningful pain relief for those living with PDN. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This clinical trial is for adults with painful diabetic neuropathy (PDN) who have not found relief from other treatments. Participants must show a significant reduction in pain during a one-week test to qualify for permanent treatment.

Inclusion Criteria

DN4 score ≥4, indicating neuropathic pain characteristics

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

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

Prior spinal cord stimulator implantation or previous SCS trial that was unsuccessful

Severe or uncontrolled psychiatric illness that, in the investigator's judgment, may interfere with study compliance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Temporary SCS Trial

Participants undergo a one-week temporary SCS trial with BurstDR stimulation to assess pain reduction

1 week

1 visit (in-person)

Permanent Implantation

Participants who achieve meaningful pain reduction proceed to permanent implantation of the SCS device

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after permanent implantation at 1, 3, and 6 months

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BurstDR Spinal Cord Stimulation

Trial Overview

The study tests the effectiveness of BurstDR Spinal Cord Stimulation using Abbott's systems on PDN. Patients will be evaluated over six months to see if this therapy can consistently reduce their pain and improve quality of life.

How Is the Trial Designed?

Group I: Test Group [Burst DR SCS] Experimental Treatment 1 Intervention

Participants receive BurstDR spinal cord stimulation delivered through Abbott Proclaim XR or Eterna systems, beginning with a temporary trial followed by permanent implantation for responders.

Who Is Running the Clinical Trial?

TriCity Research Center

Lead Sponsor

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07250828?cond=Diabetes

Efficacy and Feasibility of BurstDR SCS in Painful Diabetic ...

This prospective, single-arm clinical study evaluates the therapeutic efficacy and feasibility of BurstDR spinal cord stimulation (SCS) ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10899837/

Spinal Cord Stimulation for Painful Diabetic Neuropathy - PMC

A post hoc analysis of the outcomes in the nine patients with PDN by the same investigator team demonstrated improvements in pain score and responses to pain by ...

3.

academic.oup.com

academic.oup.com/painmedicine/article/20/Supplement_1/S47/5509422

Burst Spinal Cord Stimulation: A Systematic Review and ...

Effectiveness data—pain scores and PRO ratings—were weighted by study sample sizes and pooled. The effects of burst SCS were compared against ...

4.

dovepress.com

dovepress.com/real-world-outcomes-of-spinal-cord-stimulation-a-consecutive-instituti-peer-reviewed-fulltext-article-JPR

Real-World Outcomes of Spinal Cord Stimulation

Individuals living with diabetic neuropathy who received SCS implants had the highest success rate (83.3%), followed by NSRBP (79.6%), PLS (77.5 ...

5.

ctv.veeva.com

ctv.veeva.com/study/efficacy-and-feasibility-of-burstdr-scs-in-painful-diabetic-neuropathy

Efficacy and Feasibility of BurstDR SCS in Painful Diabetic ...

This prospective, single-arm clinical study evaluates the therapeutic efficacy and feasibility of BurstDR spinal cord stimulation (SCS) ...

6.

neuromodulation.abbott

neuromodulation.abbott/us/en/healthcare-professionals/hcp-chronic-pain/scs-nsbp.html

Nonsurgical Back Pain

Burst spinal cord stimulation evaluated in patients with failed back surgery syndrome and painful diabetic neuropathy. Neuromodulation. 2014;17(2):152-159.

7.

journals.sagepub.com

journals.sagepub.com/doi/abs/10.1177/19322968221133795

Spinal Cord Stimulation for Painful Diabetic Neuropathy

Spinal cord stimulation (SCS) technology has been recently approved by the US Food and Drug Administration (FDA) for painful diabetic neuropathy (PDN).