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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 an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the study physician.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

PDN-SENSORY Trial 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.Check my eligibility
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.See study design
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.

PDN-SENSORY Trial 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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My doctor agrees I can safely undergo the surgeries needed for this study.
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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 am willing and able to sign a consent form.
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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.
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I am willing and able to follow the study's requirements and attend all visits.
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I have tried gabapentin or similar drugs and another painkiller without enough pain relief or had bad side effects.
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I have been on a consistent pain medication plan for at least 30 days.

PDN-SENSORY Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lower limb pain responder rate
Secondary outcome measures
Average change in EQ-5D-5L index
Average change in HbA1c
Average change in IENF density at the lower calf
+7 more

PDN-SENSORY 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
7 Previous Clinical Trials
1,661 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment size for this research project?

"Affirmative. The clinicaltrials.gov database indicates that this medical trial, first published on April 15th 2023, is actively recruiting patients for participation. This research project requires 236 individuals to be recruited from 2 different healthcare facilities."

Answered by AI

Are there any openings for enrolment into this medical experiment?

"Clinicaltrials.gov reports that this clinical trial is open for enrollment, with the initial posting date of April 15th 2023. The listing has been updated as recently as April 10th 2023."

Answered by AI
~136 spots leftby Jun 2025