Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy

NCT05777317 | Active Not Recruiting FDA Device

• 1 other identifier: CA2022-2 US PDN-Sensory RCT
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this post-market study is to evaluate changes in pain and neurological function with high frequency, 10 kHz spinal cord stimulation (SCS) therapy in patients with chronic, intractable lower limb pain associated with diabetic peripheral neuropathy, a condition known as painful diabetic neuropathy (PDN). This is a multi-center, prospective, randomized controlled study to evaluate improvement in pain and neurological function in PDN patients, with neurological function assessed via objective measures. Patients will be randomized to conventional medical management (CMM) or 10 kHz SCS plus CMM.

Conditions

Painful Diabetic Neuropathy

Keywords

Diabetic Neuropathy; Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• Lower limb pain responder rate

  The lower limb pain responder rate is the proportion of subjects who are pain responders, where a responder is defined as having at least 50% reduction in average lower limb pain score from baseline as measured on a 10-cm Visual Analog Scale (VAS, where a higher score indicates greater pain.

  6 months

Secondary Outcomes (10)

• Neurological improvement responder rate

  6 months

• Lower limb pain responder rate at 3 months

  3 months

• Percent change in lower limb pain intensity

  6 months

• Percent change in PSQ-3

  6 months

• Average change in EQ-5D-5L index

  6 months

Study Arms (2)

10 kHz SCS plus CMM

EXPERIMENTAL

Treatment with high frequency, 10 kHz spinal cord stimulation (SCS) in addition to conventional medical management (CMM)

Device: 10 kHz SCS

CMM alone

ACTIVE COMPARATOR

Treatment with conventional medical management (CMM) alone

Other: CMM alone

Interventions

10 kHz SCS DEVICE

Spinal cord stimulation programmed to a frequency of 10 kHz

Also known as: Nevro HFX therapy programmed to a frequency of 10 kHz or high frequency, 10 kHz SCS

10 kHz SCS plus CMM

CMM alone OTHER

Conventional medical management alone

CMM alone

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has been clinically diagnosed with diabetes, according to the American Diabetes Association guidelines, as well as painful diabetic neuropathy (PDN) of the lower limbs.
• Has pain intensity (over the last 7 days) of ≥5 out of 10 cm on the Visual Analog Scale (VAS) in the lower limbs at both the Enrollment and Baseline Visits.
• Has PDN symptoms that have been present ≥12 months.
• Is currently taking or has tried in the past a gabapentinoid and at least one other class of analgesic with insufficient pain relief or intolerable side effects.
• Has painful diabetic sensorimotor polyneuropathy confirmed by modified Toronto Clinical Neuropathy Score (mTCNS) \>5 at enrollment. The total score must include presence of foot pain (≥1) and sensory exam findings (≥ 2).
• Has hemoglobin A1c ≤10% as measured at enrollment.
• Is 22 years of age or older at the time of enrollment.
• Is an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the study physician.
• Is willing to and capable of giving written informed consent.
• Is willing and able to comply with study-related requirements and procedures and attend all scheduled visits.

You may not qualify if:

• Has a diagnosis of a lower limb mononeuropathy (e.g., causalgia, tibial or peroneal neuropathies), has had a lower limb amputation other than toes due to diabetes, or has large (≥3 cm) and/or gangrenous ulcers or active infection of the lower limbs.
• Has an average pain intensity of ≥ 3 out of 10 cm on the VAS in the upper limbs due to diabetic neuropathy at enrollment.
• Has a history of glycemia-related hospitalizations or emergency ward visits including ketoacidosis, hyperosmolar state, severe hypoglycemia in the previous 6 months.
• Uses anticoagulants or antiplatelet agents that cannot be temporarily discontinued prior to the procedure.
• Has unstable cardiovascular disease, including untreated cardiac arrhythmias, myocardial infarction within last 12 months, New York Heart Association (NYHA) Functional Class III or IV heart failure.
• Is currently prescribed a daily opioid dosage \> 120 mg morphine equivalents.
• Has a medical condition or diagnosis that is inconsistent with the Senza System guidelines in the Physician's Manual or as per standard clinical practice.
• Has a medical condition or pain in other area(s), not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache, fibromyalgia, post-herpetic neuralgia, osteoarthritis, critical limb ischemia due to peripheral vascular disease or small vessel disease).
• Has prior experience with SCS, dorsal root ganglion (DRG) stimulation, peripheral nerve field stimulation (PNfS), or peripheral nerve stimulation (PNS) for chronic intractable pain.
• Has an existing drug pump and/or another active implantable device such as a pacemaker (ok to have an insulin pump or continuous glucose monitor that remains externalized).
• Has a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with Senza System guidelines in the Physician's Manual.
• Has a life expectancy of less than one year.
• Has a local infection at the anticipated surgical entry site or an active systemic infection.
• Is pregnant or plans to become pregnant during the study (participants of child-bearing potential that are sexually active must use a reliable form of birth control).
• Has had within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.

Sponsors & Collaborators

• Nevro Corp: lead

Study Sites (2)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

Touchstone Interventional Pain Center

Medford, Oregon, 97504, United States

Location

Related Publications (1)

• Pop-Busui R, Petersen EA, Levy BL, Tesfaye S, Armstrong DG, Grunberger G, Boulton AJ, Bharara M, Edgar D, Azalde RP, Caraway D. Evaluating pain and neurological function with high frequency 10 kHz spinal cord stimulation in the treatment of painful diabetic neuropathy: design of a multicentre, randomised controlled trial (PDN-Sensory). BMJ Open. 2025 Nov 27;15(11):e101647. doi: 10.1136/bmjopen-2025-101647.

  PMID: 41309477 DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Carubicin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Neurological exam assessors are blinded to treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 21, 2023
• Study Start: April 24, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)