- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05777317
Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy (PDN-SENSORY)
May 9, 2023 updated by: Nevro Corp
PDN-SENSORY: A Multi-Center Randomized Controlled Trial to Evaluate Pain and Neurological Function With 10 kHz SCS in Treatment of Painful Diabetic Neuropathy
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
236
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Don Middlebrook
- Phone Number: 650-433-2218
- Email: don.middlebrook@nevro.com
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Not yet recruiting
- Atrium Health Wake Forest Baptist
-
Contact:
- Lynne Harris, RN
- Phone Number: 336-306-0778
- Email: lcharris@wakehealth.edu
-
Sub-Investigator:
- Daniel Bintrim, MD
-
Sub-Investigator:
- Janus Patel, MD
-
Principal Investigator:
- Robert Hurley, MD, PhD
-
-
Oregon
-
Medford, Oregon, United States, 97504
- Recruiting
- Touchstone Interventional Pain Center
-
Contact:
- Shannon Moran
- Phone Number: 541-494-0370
- Email: shannonm@touchstonepain.com
-
Principal Investigator:
- Shawn Sills, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 10 kHz SCS plus CMM
Treatment with high frequency, 10 kHz spinal cord stimulation (SCS) in addition to conventional medical management (CMM)
|
Spinal cord stimulation programmed to a frequency of 10 kHz
Other Names:
|
Active Comparator: CMM alone
Treatment with conventional medical management (CMM) alone
|
Conventional medical management alone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower limb pain responder rate
Time Frame: 6 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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurological improvement responder rate
Time Frame: 6 months
|
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.
|
6 months
|
Lower limb pain responder rate at 3 months
Time Frame: 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.
|
3 months
|
Percent change in lower limb pain intensity
Time Frame: 6 months
|
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.
|
6 months
|
Percent change in PSQ-3
Time Frame: 6 months
|
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.
|
6 months
|
Average change in EQ-5D-5L index
Time Frame: 6 months
|
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.
|
6 months
|
Average change in NeuroQol
Time Frame: 6 months
|
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.
|
6 months
|
Average change in IENF density at the lower calf
Time Frame: 6 months
|
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.
|
6 months
|
Average change in mTCNS
Time Frame: 6 months
|
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.
|
6 months
|
Average change in HbA1c
Time Frame: 6 months
|
Average change in hemoglobin A1c (HbA1c) from baseline for patients with type 2 diabetes and HbA1c >= 8.0% at enrollment
|
6 months
|
Average change in body weight
Time Frame: 6 months
|
Average change in body weight from baseline for patients with type 2 diabetes
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2023
Primary Completion (Anticipated)
June 30, 2025
Study Completion (Anticipated)
August 31, 2026
Study Registration Dates
First Submitted
March 8, 2023
First Submitted That Met QC Criteria
March 8, 2023
First Posted (Actual)
March 21, 2023
Study Record Updates
Last Update Posted (Actual)
May 11, 2023
Last Update Submitted That Met QC Criteria
May 9, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA2022-2 US PDN-Sensory RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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