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Spinal Cord Stimulation

10 kHz Spinal Cord Stimulation for Diabetic Neuropathy (PDN-SENSORY Trial)

N/A
Waitlist Available
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 below
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My leg pain has been 5 or more out of 10 for the past week.
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I am 22 years old or older.
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I have painful diabetic nerve pain in my feet, confirmed by a specific test.
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I have had symptoms of peripheral diabetic neuropathy for over a year.
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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:
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My BMI is over 45.
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I have an infection where surgery is planned or a body-wide infection.
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I use blood thinners that can't be stopped before a procedure.
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I do not have severe heart problems or recent heart attacks.
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I have tried nerve stimulation treatments for chronic pain before.
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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 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 more

Awards & 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

10 kHz SCS (Spinal Cord Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05777317 — N/A
Diabetic Neuropathy Research Study Groups: CMM alone, 10 kHz SCS plus CMM
Diabetic Neuropathy Clinical Trial 2023: 10 kHz SCS Highlights & Side Effects. Trial Name: NCT05777317 — N/A
10 kHz SCS (Spinal Cord Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05777317 — N/A
~38 spots leftby Jun 2025
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