Efficacy and Feasibility of BurstDR SCS in Painful Diabetic Neuropathy

NCT07250828 | Enrolling By Invitation FDA Device

• 2 other identifiers: IIS-25-ABT-002ABT-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Painful Diabetic Neuropathy (PDN); Diabetic Neuropathy; Neuropathic Pain; Chronic Pain

Keywords

Painful Diabetic Neuropathy; Diabetic Neuropathy; Neuropathic Pain; Spinal Cord Stimulation; BurstDR; Proclaim XR; Eterna SCS; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• VAS Change Baseline to 6 Month

  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.

  1 month, 3 months, and 6 months

Secondary Outcomes (3)

• Diabetes QoL Change Baseline to 6 Months

  1 month, 3 months, and 6 months after permanent implantation

• Change in DN4 neuropathic pain score

  1 month, 3 months, and 6 months after permanent implantation

• Change in pain-related sleep interference (PSQ-3)

  1 month, 3 months, and 6 months after permanent implantation

Study Arms (1)

Test Group [Burst DR SCS]

EXPERIMENTAL

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.

Device: BurstDR Spinal Cord Stimulation

Interventions

BurstDR Spinal Cord Stimulation DEVICE

Participants receive BurstDR spinal cord stimulation delivered through Abbott Proclaim XR or Eterna spinal cord stimulator systems in a standard of care routine. The intervention includes a one-week temporary SCS trial using percutaneous leads, followed by permanent implantation of the Proclaim XR or Eterna implantable pulse generator for participants who experience meaningful pain relief during the trial. Device programming and follow-up assessments follow standard clinical practice.

Also known as: Proclaim, Eterna, Burst DR, Spinal Cord Stimulator

Test Group [Burst DR SCS]

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• TriCity Research Center: lead
• Abbott: collaborator

Study Sites (1)

Grand Island Pain Relief Center

Grand Island, Nebraska, 68803, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Neuralgia; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label study. No parties are masked
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm study in which all participants receive BurstDR spinal cord stimulation using Abbott Proclaim XR or Eterna systems.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)