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A Prospective, Randomized, Controlled Trial of High Frequency Spinal Cord Stimulation for the Treatment of Neuropathic Limb Pain from Painful Diabetic Neuropathy: The SENZA-PDN Protocol
Session: EX-05
Thurs, April 19, 6:30-6:40 pm
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A Prospective, Randomized, Controlled Trial of High Frequency Spinal Cord Stimulation for the Treatment of Neuropathic Limb Pain from Painful Diabetic Neuropathy: The SENZA-PDN Protocol

Charles Argoff, MD1 Nagy Mekhail, MD PhD2 Christian Nasr, MD2 Rod Taylor, PhD3 Peter Neumann, ScD4 David Caraway, MD PhD5 Brad Gliner, MS5 Jeyakumar Subbaroyan, PhD5 Lisa Brooks, PhD5

1Albany Medical Center, Albany, NY; 2Cleveland Clinic Foundation, Cleveland, OH; 3University of Exeter, Exeter Medical School, UK; 4Tufts Medical Center, Boston, MA; 5Nevro Corp., Redwood City, CA

Introduction: Data from the Centers for Disease Control and Prevention (CDC) estimate in the United States there are currently1:

- 29 million people living with diabetes

- 86 million people with prediabetes
 
- resulting in $245 billion in annual healthcare costs and lost productivity

Approximately 20% of diabetic patients will develop painful diabetic neuropathy (PDN),2 a debilitating, progressive chronic pain condition that significantly impacts the patient’s health-related quality of life. Current treatments are primarily pharmacological, including anticonvulsants, antidepressants, opiates, and topical agents;3 however, substantial numbers of PDN patients discontinue medications due to lack of efficacy or intolerable side effects4 (Table 1).

Traditional, low frequency spinal cord stimulation (SCS) has also been applied in this patient population.5,6 Neither pharmacological treatments nor low frequency SCS has provided significant, long-term pain relief for PDN patients, thus there is a large unmet clinical need in this population. Data from a small, prospective study using high frequency SCS (HF-SCS) at 10 kHz for the treatment of peripheral polyneuropathy suggest that this therapy could provide a new treatment option for PDN (Figure 1).7 In addition to pain relief, 48% of subjects displayed improvements on neurological examination with HF-SCS at 10 kHz treatment.

Study Design:

- Prospective, multicenter, randomized, controlled trial
- 216 subjects with PDN randomized 1:1
- HF-SCS at 10 kHz combined with conventional medical management (CMM)
- CMM alone
- 24 month follow-up

Key inclusion criteria

1)Diagnosis of PDN for at least 12 mo
2)Pain intensity in the lower limbs of at least 5 out of 10 cm on the visual analog scale (VAS)
3)Appropriate candidate for SCS

Key exclusion criteria

1)Lower limb amputation
2)Large and/or gangrenous ulcers
3)Pain intensity in the upper limbs of at least 3 out of 10 cm on the VAS
 

Data collection 

- Pain VAS
- Neurological assessment
- Health-related quality of life
- Sleep quality
- Patient satisfaction

Primary endpoint 

- Compare responder rates (≥ 50% pain relief) and safety rates between treatment groups
- Assessed at 3 months

Several secondary endpoints will also be reported. There may be increased risk with SCS perioperative infections in patients with diabetes.8 We will quantify the infection rate in this study population and compare it with prior observations of diabetic cohorts. Each clinical site will obtain Institutional Review Board approval and each individual subject will provide written informed consent prior to participating in the study.

Results: Enrollment in the SENZA-PDN study commenced in August, 2017, and is expected to be complete in 2019.

Conclusions: The SENZA-PDN study will be the largest RCT conducted using SCS in subjects with PDN, a growing patient population with unmet clinical needs. This prospective, multicenter study will determine whether HF-SCS at 10 kHz improves clinical outcomes, health-related quality of life, and is a cost-effective treatment for PDN.

References

1. CDC National Diabetes Statistics Report 2014.

2. Schmader KE. Clin J Pain 2002 Nov-Dec;18(6):350-4.

3. ADA Position Statement of Diabetic Neuropathy. Diabetes Care 2017;40:136-54.

4. Yang M et al. Pain Med 2015;16:2075-83.

5. de Vos CC et al. Pain 2014;155:2426-31.

6. van Beek M et al. Diabetes Care 2018;41:32-8.

7. Galan V et al. NANS 2018.

8. Mekail N et al. Pain Practice 2011;11(2):148-53

Disclosure: This study is funded by Nevro Corp.

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