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Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy (PDN-SENSORY)

Primary Purpose

Painful Diabetic Neuropathy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
10 kHz SCS
CMM alone
Sponsored by
Nevro Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Painful Diabetic Neuropathy focused on measuring Diabetic Neuropathy, Spinal Cord Stimulation

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 been on a stable analgesic regimen, as determined by the Investigator, for at least 30 days prior to assessing pain intensity as described in inclusion criterion #2. 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. Exclusion Criteria: 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. Is concomitantly participating in another interventional clinical study. Is involved in an injury claim for study-related chronic pain that is under current litigation. Is a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to study-related chronic pain. Has a pending or approved worker's compensation claim for study-related chronic pain. Has evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome, as determined by the investigator in the last 12 months. Has a BMI > 45 at enrollment.

Sites / Locations

  • Atrium Health Wake Forest Baptist
  • Touchstone Interventional Pain CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

10 kHz SCS plus CMM

CMM alone

Arm Description

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

Treatment with conventional medical management (CMM) alone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Neurological improvement responder rate
The neurological improvement responder rate is the proportion of subjects who are neurological improvement responders, where a responder is defined as having a decrease of at least 3 points, excluding changes in foot pain under symptom scores, as assessed via the modified Toronto Clinical Neuropathy Score (mTCNS). The mTCNS assesses the severity of symptoms and sensory function loss associated with diabetic neuropathy. All symptom and sensory test scores are summed to provide a total mTCNS score for each assessment. The mTCNS has a maximum score of 33, where a higher score indicates greater neuropathy severity.
Lower limb pain responder rate at 3 months
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.
Percent change in lower limb pain intensity
Percent change in average lower limb pain intensity from baseline as measured on a 10-cm Visual Analog Scale (VAS), where a higher score indicates greater pain.
Percent change in PSQ-3
Percent change in Pain and Sleep Questionnaire Three-Item Index (PSQ-3) score from baseline. PSQ-3 is a three-item questionnaire to assess the impact of chronic pain on sleep. Each question is answered on a 10-cm Visual Analog Scale (VAS), and the final score is the average of the three responses. A higher score indicates greater impact of chronic pain on sleep.
Average change in EQ-5D-5L index
Average change in EuroQol 5-dimension 5-level (EQ-5D-5L) index score from baseline. EQ-5D-5L measures the subject's health state as assessed in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with 5 levels. The scores on these five dimensions can be presented as a health profile or can be converted to a single number summary called the "index value." A higher index score indicates higher quality of life.
Average change in NeuroQol
Average change in Neuropathy-Specific Quality of Life Questionnaire (NeuroQol) score from baseline. The NeuroQol measures a patient's perception of the impact diabetic peripheral neuropathy and foot ulcers on quality of life. Each question uses a 5-point Likert scale from 1 ("never") to 5 ("all the time") for frequency of symptoms. A higher NeuroQol value indicates greater impact of diabetic neuropathy on quality of life.
Average change in IENF density at the lower calf
Average change in intraepidermal nerve fiber (IENF) density at the lower calf from baseline. IENF is a measure of small nerve fiber density in the skin, with a higher value indicating greater density of nerve fibers.
Average change in mTCNS
Average change in the modified Toronto Clinical Neuropathy Score (mTCNS) from baseline. The mTCNS assesses the severity of symptoms and sensory function loss associated with diabetic neuropathy. All symptom and sensory test scores are summed to provide a total mTCNS score for each assessment. The mTCNS has a maximum score of 33, where a higher score indicates greater severity of neuropathy.
Average change in HbA1c
Average change in hemoglobin A1c (HbA1c) from baseline for patients with type 2 diabetes and HbA1c >= 8.0% at enrollment
Average change in body weight
Average change in body weight from baseline for patients with type 2 diabetes

Full Information

First Posted
March 8, 2023
Last Updated
May 9, 2023
Sponsor
Nevro Corp
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1. Study Identification

Unique Protocol Identification Number
NCT05777317
Brief Title
Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy
Acronym
PDN-SENSORY
Official Title
PDN-SENSORY: A Multi-Center Randomized Controlled Trial to Evaluate Pain and Neurological Function With 10 kHz SCS in Treatment of Painful Diabetic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nevro Corp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Diabetic Neuropathy
Keywords
Diabetic Neuropathy, Spinal Cord Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Neurological exam assessors are blinded to treatment assignment
Allocation
Randomized
Enrollment
236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10 kHz SCS plus CMM
Arm Type
Experimental
Arm Description
Treatment with high frequency, 10 kHz spinal cord stimulation (SCS) in addition to conventional medical management (CMM)
Arm Title
CMM alone
Arm Type
Active Comparator
Arm Description
Treatment with conventional medical management (CMM) alone
Intervention Type
Device
Intervention Name(s)
10 kHz SCS
Other Intervention Name(s)
Nevro HFX therapy programmed to a frequency of 10 kHz or high frequency, 10 kHz SCS
Intervention Description
Spinal cord stimulation programmed to a frequency of 10 kHz
Intervention Type
Other
Intervention Name(s)
CMM alone
Intervention Description
Conventional medical management alone
Primary Outcome Measure Information:
Title
Lower limb pain responder rate
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Neurological improvement responder rate
Description
The neurological improvement responder rate is the proportion of subjects who are neurological improvement responders, where a responder is defined as having a decrease of at least 3 points, excluding changes in foot pain under symptom scores, as assessed via the modified Toronto Clinical Neuropathy Score (mTCNS). The mTCNS assesses the severity of symptoms and sensory function loss associated with diabetic neuropathy. All symptom and sensory test scores are summed to provide a total mTCNS score for each assessment. The mTCNS has a maximum score of 33, where a higher score indicates greater neuropathy severity.
Time Frame
6 months
Title
Lower limb pain responder rate at 3 months
Description
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.
Time Frame
3 months
Title
Percent change in lower limb pain intensity
Description
Percent change in average lower limb pain intensity from baseline as measured on a 10-cm Visual Analog Scale (VAS), where a higher score indicates greater pain.
Time Frame
6 months
Title
Percent change in PSQ-3
Description
Percent change in Pain and Sleep Questionnaire Three-Item Index (PSQ-3) score from baseline. PSQ-3 is a three-item questionnaire to assess the impact of chronic pain on sleep. Each question is answered on a 10-cm Visual Analog Scale (VAS), and the final score is the average of the three responses. A higher score indicates greater impact of chronic pain on sleep.
Time Frame
6 months
Title
Average change in EQ-5D-5L index
Description
Average change in EuroQol 5-dimension 5-level (EQ-5D-5L) index score from baseline. EQ-5D-5L measures the subject's health state as assessed in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with 5 levels. The scores on these five dimensions can be presented as a health profile or can be converted to a single number summary called the "index value." A higher index score indicates higher quality of life.
Time Frame
6 months
Title
Average change in NeuroQol
Description
Average change in Neuropathy-Specific Quality of Life Questionnaire (NeuroQol) score from baseline. The NeuroQol measures a patient's perception of the impact diabetic peripheral neuropathy and foot ulcers on quality of life. Each question uses a 5-point Likert scale from 1 ("never") to 5 ("all the time") for frequency of symptoms. A higher NeuroQol value indicates greater impact of diabetic neuropathy on quality of life.
Time Frame
6 months
Title
Average change in IENF density at the lower calf
Description
Average change in intraepidermal nerve fiber (IENF) density at the lower calf from baseline. IENF is a measure of small nerve fiber density in the skin, with a higher value indicating greater density of nerve fibers.
Time Frame
6 months
Title
Average change in mTCNS
Description
Average change in the modified Toronto Clinical Neuropathy Score (mTCNS) from baseline. The mTCNS assesses the severity of symptoms and sensory function loss associated with diabetic neuropathy. All symptom and sensory test scores are summed to provide a total mTCNS score for each assessment. The mTCNS has a maximum score of 33, where a higher score indicates greater severity of neuropathy.
Time Frame
6 months
Title
Average change in HbA1c
Description
Average change in hemoglobin A1c (HbA1c) from baseline for patients with type 2 diabetes and HbA1c >= 8.0% at enrollment
Time Frame
6 months
Title
Average change in body weight
Description
Average change in body weight from baseline for patients with type 2 diabetes
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 been on a stable analgesic regimen, as determined by the Investigator, for at least 30 days prior to assessing pain intensity as described in inclusion criterion #2. 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. Exclusion Criteria: 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. Is concomitantly participating in another interventional clinical study. Is involved in an injury claim for study-related chronic pain that is under current litigation. Is a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to study-related chronic pain. Has a pending or approved worker's compensation claim for study-related chronic pain. Has evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome, as determined by the investigator in the last 12 months. Has a BMI > 45 at enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Don Middlebrook
Phone
650-433-2218
Email
don.middlebrook@nevro.com
Facility Information:
Facility Name
Atrium Health Wake Forest Baptist
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynne Harris, RN
Phone
336-306-0778
Email
lcharris@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Robert Hurley, MD, PhD
First Name & Middle Initial & Last Name & Degree
Daniel Bintrim, MD
First Name & Middle Initial & Last Name & Degree
Janus Patel, MD
Facility Name
Touchstone Interventional Pain Center
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon Moran
Phone
541-494-0370
Email
shannonm@touchstonepain.com
First Name & Middle Initial & Last Name & Degree
Shawn Sills, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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