Your session is about to expire
← Back to Search
Spinal Cord Stimulation
10 kHz Spinal Cord Stimulation for Diabetic Neuropathy (PDN-SENSORY Trial)
N/A
Recruiting
Research Sponsored by Nevro Corp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Is 22 years of age or older at the time of enrollment.
Must not have
Has a BMI > 45 at enrollment.
Has a local infection at the anticipated surgical entry site or an active systemic infection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if high frequency spinal cord stimulation can reduce pain & improve neurological function in patients with diabetic neuropathy. #medicaltrial
Who is the study for?
This trial is for adults over 22 with chronic lower limb pain from diabetic neuropathy, who've had stable pain medication use and a hemoglobin A1c ≤10%. They should have tried multiple pain relief methods without success. Exclusions include severe cardiovascular issues, high opioid use, certain psychological conditions, BMI >45, or other conflicting medical devices or conditions.
What is being tested?
The study tests if a high-frequency spinal cord stimulation (SCS) at 10 kHz plus conventional medical management (CMM) can better manage pain and improve neurological function in patients with painful diabetic neuropathy compared to CMM alone. Participants are randomly assigned to one of the two groups.
What are the potential side effects?
While not explicitly stated here, typical side effects of SCS may include infection at the implant site, bleeding, headache, allergic reaction to device materials or worsening pain. Side effects vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leg pain has been 5 or more out of 10 for the past week.
Select...
I am 22 years old or older.
Select...
I have painful diabetic nerve pain in my feet, confirmed by a specific test.
Select...
I have had symptoms of peripheral diabetic neuropathy for over a year.
Select...
I have diabetes and painful nerve damage in my legs.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My BMI is over 45.
Select...
I have an infection where surgery is planned or a body-wide infection.
Select...
I use blood thinners that can't be stopped before a procedure.
Select...
I do not have severe heart problems or recent heart attacks.
Select...
I have tried nerve stimulation treatments for chronic pain before.
Select...
I take more than 120 mg of morphine or its equivalent daily.
Select...
My average pain from diabetic nerve damage in my arms is at least a 3 out of 10.
Select...
I have nerve damage in my leg, had a leg amputation due to diabetes, or have large ulcers or infection in my leg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Lower limb pain responder rate
Secondary study objectives
Average change in EQ-5D-5L index
Average change in HbA1c
Average change in IENF density at the lower calf
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 10 kHz SCS plus CMMExperimental Treatment1 Intervention
Treatment with high frequency, 10 kHz spinal cord stimulation (SCS) in addition to conventional medical management (CMM)
Group II: CMM aloneActive Control1 Intervention
Treatment with conventional medical management (CMM) alone
Find a Location
Who is running the clinical trial?
Nevro CorpLead Sponsor
8 Previous Clinical Trials
1,676 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not expected to live for more than a year.You are receiving temporary Social Security Disability Insurance (SSDI) benefits because of ongoing pain related to the study.My BMI is over 45.My leg pain has been 5 or more out of 10 for the past week.My doctor agrees I can safely undergo the surgeries needed for this study.I am willing and able to sign a consent form.I use blood thinners that can't be stopped before a procedure.I have had symptoms of peripheral diabetic neuropathy for over a year.I do not have severe heart problems or recent heart attacks.I have diabetes and painful nerve damage in my legs.Your hemoglobin A1c level is less than or equal to 10%.I have tried nerve stimulation treatments for chronic pain before.You have an active implantable device like a pacemaker or drug pump, but it's okay if you have an external insulin pump or continuous glucose monitor.I take more than 120 mg of morphine or its equivalent daily.I am willing and able to follow the study's requirements and attend all visits.You have a medical condition or pain in other areas that could make it hard to do the study procedures or report pain accurately.I have tried gabapentin or similar drugs and another painkiller without enough pain relief or had bad side effects.I am 22 years old or older.I have painful diabetic nerve pain in my feet, confirmed by a specific test.I have an infection where surgery is planned or a body-wide infection.I have been hospitalized or visited the ER for serious blood sugar issues in the last 6 months.My average pain from diabetic nerve damage in my arms is at least a 3 out of 10.I have nerve damage in my leg, had a leg amputation due to diabetes, or have large ulcers or infection in my leg.I have been on a consistent pain medication plan for at least 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: CMM alone
- Group 2: 10 kHz SCS plus CMM
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger