Painful Diabetic NeuropathySENZA-PDNNCT03228420

Comparison of 10 kHz SCS Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb Pain

A study testing Senza HF10 Therapy and CMM in people with Painful Diabetic Neuropathy, run by Nevro Corp at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This post-market study is being conducted to document comparative safety, clinical effectiveness, and cost-effectiveness of the addition of HF10™ therapy to CMM compared with CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy (Painful Diabetic Neuropathy or PDN). Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Painful Diabetic Neuropathy
What is being tested?: Senza HF10 Therapy and CMM
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 430 participants
Where: 4 sitesUnited States
Study dates: 20 Jul 2017to 28 Nov 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have been clinically diagnosed with painful diabetic neuropathy (PDN) of the lower limbs.
Average pain intensity of ≥ 5 out of 10 cm on the VAS in the lower extremities at enrollment.
Have stable neurological status.
Be on a stable analgesic regimen.
Be 22 years of age or older at the time of enrollment.
Be an appropriate candidate for the surgical procedures required in this study.

Show all 9Show fewer

Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English.
Be willing and capable of giving informed consent.
Be willing and able to comply with study-related requirements, procedures, and scheduled visits.

Who cannot join

Have a diagnosis of a lower limb mononeuropathy, have had a lower limb amputation, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.
Have a BMI ≥ 40.
Currently prescribed a daily opioid dosage > 120 mg morphine equivalents.
Have a medical condition or pain in other area(s), not intended to be treated in this study.
Have a current diagnosis of a progressive neurological disease such a multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury.
Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, low platelet count, severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.

Show all 22Show fewer

Have failed prior SCS, dorsal root ganglion (DRG) stimulation, or peripheral nerve stimulation (PNS) trials for chronic intractable pain.
Have significant spinal stenosis, objective evidence of epidural scarring and/or any signs or symptoms of myelopathy.
Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) resulting in a compromised epidural space.
Be benefitting from an interventional procedure and/or surgery to treat lower limb pain.
Have an existing drug pump and/or another active implantable device such as a pacemaker.
Have 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.
Have either a metastatic malignant neoplasm or untreated local malignant neoplasm.
Have a life expectancy of less than one year.
Have a local infection at the anticipated surgical entry site or an active systemic infection.
Be pregnant or plan to become pregnant during the study. Women of childbearing potential who are sexually active must use a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal.
Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
Be concomitantly participating in another clinical study.
Be involved in an injury claim under current litigation.
Be a recipient of Social Security Disability Insurance (SSDI).
Have a pending or approved worker's compensation claim.
Have 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Coastal Orthopedics
Bradenton, Florida, 34209
Duke University Medical Center
Durham, North Carolina, 27710
Advanced Pain Management
Greenfield, Wisconsin, 53221
Georgia Pain Care
Stockbridge, Georgia, 30281

Other trials in United States

About this study

Official title: A Post-Market, Multicenter, Prospective, Randomized Clinical Trial Comparing 10 kHz Spinal Cord Stimulation (HF10™ Therapy) Combined With Conventional Medical Management to Conventional Medical Management Alone in the Treatment of Chronic, Intractable, Neuropathic Limb Pain

Conditions: Painful Diabetic Neuropathy
Being tested: Senza HF10 Therapy, CMM
Medical subject headings: Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Senza HF10 TherapyDevice
Senza 10kHz Spinal Cord Stimulation
CMMOther
Conventional Medical Management

Study groups in NCT03228420
Study group	Role	What they receive
HF10 therapy plus CMM	Active comparator	The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management Receives: Device: Senza HF10 Therapy
CMM Alone	Other	Conventional Medical Management Receives: Other: CMM

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite of Safety and Effectiveness
Difference between treatment groups in responder rates in subjects without a clinically meaningful neurological deficit compared with baseline. Responder is defined as a subject who has at least 50% reduction in lower limb pain from Baseline as measured by a 10 cm Visual Analog Scale (VAS).
Measured: 3 months

Secondary outcomes (8)

Pain Scores of 3 or Less
Difference between the treatment groups in proportion of subjects with a lower limb pain VAS score ≤ 3 cm.
Measured: 3 months
Crossover Rates
Difference between the treatment groups in crossover rates. Subjects who meet pre-specified criteria may elect to crossover to the other treatment arm at 6-month follow-up.
Measured: 6 months
Responder Rates
Difference between the treatment groups in responder rates. Responder is defined as a subject who has at least 50% reduction in lower limb pain from Baseline as measured by a 10 cm Visual Analog Scale (VAS).
Measured: 6 months
Remitter Rates
Difference between the treatment groups in the proportion of remitters (remission is defined as having a lower limb pain VAS score of ≤ 3.0 cm for at least 6 months).
Measured: 6 months
Neurological Assessment
Difference between the treatment groups in the proportion of subjects with overall improvement from baseline in neurological assessment (motor, sensory, reflex).
Measured: 3 months
Neurological Assessment
Difference between the treatment groups in the proportion of subjects with overall improvement from baseline in neurological assessment (motor, sensory, reflex).
Measured: 6 months
Health-related Quality of Life
Difference between the treatment groups in changes in health-related quality of life as assessed by the EuroQol Five Dimensions questionnaire (EQ-5D-5L).
Measured: 6 months
Hemoglobin A1c
Difference between the treatment groups in the average percentage change from baseline in HbA1c levels.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 201728 Nov 2022

First posted24 Jul 2017
Study start20 Jul 2017
Primary completion1 May 2020
Study completion28 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Painful Diabetic NeuropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 430 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03228420
Sponsor's protocol ID: CA2016-5
Acronym: SENZA-PDN
Status last verified: Jun 2026
First submitted: 12 Jul 2017
Last updated: 21 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Klonoff DC, Levy BL, Jaasma MJ, Bharara M, Edgar DR, Nasr C, Caraway DL, Petersen EA, Armstrong DG. Treatment of Painful Diabetic Neuropathy with 10 kHz Spinal Cord Stimulation: Long-Term Improvements in Hemoglobin A1c, Weight, and Sleep Accompany Pain Relief for People with Type 2 Diabetes. J Pain Res. 2024 Sep 18;17:3063-3074. doi: 10.2147/JPR.S463383. eCollection 2024.
PubMed 39308991
Argoff CE, Armstrong DG, Kagan ZB, Jaasma MJ, Bharara M, Bradley K, Caraway DL, Petersen EA; for Investigators. Improvement in Protective Sensation: Clinical Evidence From a Randomized Controlled Trial for Treatment of Painful Diabetic Neuropathy With 10 kHz Spinal Cord Stimulation. J Diabetes Sci Technol. 2025 Jul;19(4):992-998. doi: 10.1177/19322968231222271. Epub 2024 Jan 9.
PubMed 38193426
Petersen EA, Stauss TG, Scowcroft JA, Jaasma MJ, Brooks ES, Edgar DR, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Mehta ND, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Argoff CE, Nasr CE, Taylor RS, Caraway DL, Mekhail NA. Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial. Diabetes Res Clin Pract. 2023 Sep;203:110865. doi: 10.1016/j.diabres.2023.110865. Epub 2023 Aug 1.
PubMed 37536514
Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Mehta ND, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Argoff CE, Nasr CE, Taylor RS, Caraway DL, Mekhail NA. High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial. Mayo Clin Proc Innov Qual Outcomes. 2022 Jul 1;6(4):347-360. doi: 10.1016/j.mayocpiqo.2022.05.003. eCollection 2022 Aug.
PubMed 35814185
Armstrong DG, Grunberger G. Stimulating Results Signal a New Treatment Option for People Living With Painful Diabetic Neuropathy. J Diabetes Sci Technol. 2023 Sep;17(5):1387-1391. doi: 10.1177/19322968221099542. Epub 2022 Jun 30.
PubMed 35770993
O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
PubMed 34854473
Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Mehta ND, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Argoff CE, Nasr CE, Taylor RS, Caraway DL, Mekhail NA. Durability of High-Frequency 10-kHz Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy Refractory to Conventional Treatments: 12-Month Results From a Randomized Controlled Trial. Diabetes Care. 2022 Jan 1;45(1):e3-e6. doi: 10.2337/dc21-1813. No abstract available.
PubMed 34844993
Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Paul CA, Mehta ND, Choi H, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Gekht G, Argoff CE, Nasr CE, Taylor RS, Subbaroyan J, Gliner BE, Caraway DL, Mekhail NA. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):687-698. doi: 10.1001/jamaneurol.2021.0538.
PubMed 33818600
Mekhail NA, Argoff CE, Taylor RS, Nasr C, Caraway DL, Gliner BE, Subbaroyan J, Brooks ES. High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN). Trials. 2020 Jan 15;21(1):87. doi: 10.1186/s13063-019-4007-y.
PubMed 31941531

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies

All Painful Diabetic Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-Market, Multicenter, Prospective, Randomized Clinical Trial Comparing 10 kHz Spinal Cord Stimulation (HF10™ Therapy) Combined With Conventional Medical Management to Conventional Medical Management Alone in the Treatment of Chronic, Intractable, Neuropathic Limb Pain
ClinicalTrials.gov ID: NCT03228420
Acronym / sponsor ID: SENZA-PDN / CA2016-5
Conditions: Painful Diabetic Neuropathy
Study type: Interventional
Recruitment status: Completed
Enrolment: 430 participants (actual)
Lead sponsor: Nevro CorpIndustry (pharma, biotech, devices)
Study start: 20 Jul 2017 (actual)
Primary completion: 1 May 2020 (actual)
Study completion: 28 Nov 2022 (actual)
First posted: 24 Jul 2017 (actual)
Results: Posted 10 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
HF10 therapy plus CMM	Active comparator	Device: Senza HF10 TherapyThe addition of HF10 (10kHz SCS) therapy to Conventional Medical Management
CMM Alone	Other	Other: CMMConventional Medical Management

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Have been clinically diagnosed with painful diabetic neuropathy (PDN) of the lower limbs.
Average pain intensity of ≥ 5 out of 10 cm on the VAS in the lower extremities at enrollment.
Have stable neurological status.
Be on a stable analgesic regimen.
Be 22 years of age or older at the time of enrollment.

Key exclusion criteria (22 listed)

Have a diagnosis of a lower limb mononeuropathy, have had a lower limb amputation, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.
Have a BMI ≥ 40.
Currently prescribed a daily opioid dosage > 120 mg morphine equivalents.
Have a medical condition or pain in other area(s), not intended to be treated in this study.
Have a current diagnosis of a progressive neurological disease such a multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Senza HF10 TherapySenza 10kHz Spinal Cord Stimulation	Device	HF10 therapy plus CMM
CMMConventional Medical Management	Other	CMM Alone

Primary outcome

Composite of Safety and Effectiveness
Time frame: 3 months
Difference between treatment groups in responder rates in subjects without a clinically meaningful neurological deficit compared with baseline. Responder is defined as a subject who has at least 50% reduction in lower limb pain from Baseline as measured by a 10 cm Visual Analog Scale (VAS).

8 secondary outcomes

Pain Scores of 3 or Less
Time frame: 3 months
Crossover Rates
Time frame: 6 months
Responder Rates
Time frame: 6 months
Remitter Rates
Time frame: 6 months
Neurological Assessment
Time frame: 3 months
Neurological Assessment
Time frame: 6 months
Health-related Quality of Life
Time frame: 6 months
Hemoglobin A1c
Time frame: 6 months

Results and safety

Results posted to the registry on 10 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HF10 Therapy Plus CMM	113	93
CMM Alone	103	98

Primary outcome: Composite of Safety and Effectiveness

Time frame: 3 months. Count of participants. Unit: Participants

Measure	HF10 Therapy Plus CMM n = 95	CMM Alone n = 94
Value	75	5

HF10 Therapy Plus CMM vs CMM Alone: p <0.001, Fisher Exact

Population analysed: Intention-to-treat population including all randomized patients whose status could be determined at the 3-month primary assessment, including patients who failed trial SCS and those who withdrew due to an adverse event at any point after the trial SCS phase in the active treatment arm.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HF10 Therapy Plus CMM	12 of 113 (10.6%)	0 of 113 (0%)	1 of 113
CMM Alone	9 of 103 (8.7%)	0 of 103 (0%)	0 of 103

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39308991Klonoff DC, Levy BL, Jaasma MJ, Bharara M, Edgar DR, Nasr C, Caraway DL, Petersen EA, Armstrong DG. Treatment of Painful Diabetic Neuropathy with 10 kHz Spinal Cord Stimulation: Long-Term Improvements in Hemoglobin A1c, Weight, and Sleep Accompany Pain Relief for People with Type 2 Diabetes. J Pain Res. 2024 Sep 18;17:3063-3074. doi: 10.2147/JPR.S463383. eCollection 2024.
Derived from this study: PubMed 38193426Argoff CE, Armstrong DG, Kagan ZB, Jaasma MJ, Bharara M, Bradley K, Caraway DL, Petersen EA; for Investigators. Improvement in Protective Sensation: Clinical Evidence From a Randomized Controlled Trial for Treatment of Painful Diabetic Neuropathy With 10 kHz Spinal Cord Stimulation. J Diabetes Sci Technol. 2025 Jul;19(4):992-998. doi: 10.1177/19322968231222271. Epub 2024 Jan 9.
Derived from this study: PubMed 37536514Petersen EA, Stauss TG, Scowcroft JA, Jaasma MJ, Brooks ES, Edgar DR, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Mehta ND, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Argoff CE, Nasr CE, Taylor RS, Caraway DL, Mekhail NA. Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial. Diabetes Res Clin Pract. 2023 Sep;203:110865. doi: 10.1016/j.diabres.2023.110865. Epub 2023 Aug 1.
Derived from this study: PubMed 35814185Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Mehta ND, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Argoff CE, Nasr CE, Taylor RS, Caraway DL, Mekhail NA. High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial. Mayo Clin Proc Innov Qual Outcomes. 2022 Jul 1;6(4):347-360. doi: 10.1016/j.mayocpiqo.2022.05.003. eCollection 2022 Aug.
Derived from this study: PubMed 35770993Armstrong DG, Grunberger G. Stimulating Results Signal a New Treatment Option for People Living With Painful Diabetic Neuropathy. J Diabetes Sci Technol. 2023 Sep;17(5):1387-1391. doi: 10.1177/19322968221099542. Epub 2022 Jun 30.
Derived from this study: PubMed 34854473O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
Derived from this study: PubMed 34844993Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Mehta ND, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Argoff CE, Nasr CE, Taylor RS, Caraway DL, Mekhail NA. Durability of High-Frequency 10-kHz Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy Refractory to Conventional Treatments: 12-Month Results From a Randomized Controlled Trial. Diabetes Care. 2022 Jan 1;45(1):e3-e6. doi: 10.2337/dc21-1813. No abstract available.
Derived from this study: PubMed 33818600Petersen EA, Stauss TG, Scowcroft JA, Brooks ES, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Paul CA, Mehta ND, Choi H, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Gekht G, Argoff CE, Nasr CE, Taylor RS, Subbaroyan J, Gliner BE, Caraway DL, Mekhail NA. Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):687-698. doi: 10.1001/jamaneurol.2021.0538.
Derived from this study: PubMed 31941531Mekhail NA, Argoff CE, Taylor RS, Nasr C, Caraway DL, Gliner BE, Subbaroyan J, Brooks ES. High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN). Trials. 2020 Jan 15;21(1):87. doi: 10.1186/s13063-019-4007-y.

Related trials for Painful Diabetic Neuropathy

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Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Caraway, MD study director

Nevro Corp

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Senza HF10 Therapy and CMM in people with Painful Diabetic Neuropathy, run by Nevro Corp at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Safety and Effectiveness (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03228420, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.