Painful Diabetic NeuropathyNCT03769675

Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation

A study testing High Frequency Spinal Cord Stimulator in people with Painful Diabetic Neuropathy, run by Mayo Clinic at 1 site in United States.

Completed

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

Official record

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Trial summary

Will participants with painful lower extremity diabetic peripheral neuropathy (DPN) that are treated with high frequency spinal cord stimulation (HF10 SCS) have improvements in lower extremity peripheral nerve function? Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Painful Diabetic Neuropathy
What is being tested?: High Frequency Spinal Cord Stimulator
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 20 Nov 2018to 15 Apr 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes mellitus
Refractory predominantly lower extremity neuropathic pain for > 1 year
Presence of length dependent peripheral neuropathy on sudomotor testing
Completed spinal cord stimulation trial with 40% or greater pain reduction from baseline
Failed medication trials or contraindication to gabapentin medications (gabapentin, pregabalin) and/or serotonin/norepinephrine reuptake inhibitors (tricyclic antidepressant (TCA) or duloxetine or venlafaxine)
Average pain score on a visual analog scale (VAS) of ≥ 5 (with 0 representing no pain and 10 the worst pain imaginable)
Appropriate surgical candidate for spinal cord stimulator

Who cannot join

Severe Autonomic Neuropathy as measured by the composite autonomic scoring scale (10 point scale) with a score ≥ 7
History of sympathectomy
Uncontrolled arterial hypertension (Systolic Blood Pressure >160)
Baseline Foot TcPO2 < 10 mmHg to exclude patients with severe peripheral arterial disease
Hemoglobin A1c > 8%
Stable opioid regimen with oral morphine equivalent ≥ 100 mg/day

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Alternative principle cause for peripheral neuropathy or lower extremity neuropathic pain
Disruptive psychiatric disorder (screened for during preoperative psychiatric evaluation)
Pending litigations
Women of child bearing potential unwilling to use contraception or found to be pregnant as part of perioperative screening
Patients unable to hold medications that would impact autonomic testing

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation: (QUANT) HF10 Study

Read the detailed description

This research study is being conducted to find out if spinal cord stimulation (SCS) can improve nerve function. SCS is FDA approved for the treatment of intractable neuropathic (nerve) pain related to diabetic peripheral neuropathy. With SCS a wire is placed in the epidural space and the spinal cord is stimulated to interrupt the pain signal coming from the legs. The spinal cord stimulator is a device similar to a pacemaker (which helps treat abnormal rhythms of the heart). Recent studies have suggested that SCS with high frequencies can improve nerve function for subjects with painful peripheral neuropathy therefore, the investigators are looking to measure changes in nerve function after SCS for treatment of painful diabetic peripheral neuropathy.

The purpose of this research is to gather information on the effect of high frequency spinal cord stimulation (HF10) on nerve function with a spinal cord stimulator.

Conditions: Painful Diabetic Neuropathy
Being tested: High Frequency Spinal Cord Stimulator
Keywords: spinal cord stimulation, type 2 diabetes
Medical subject headings: Diabetic Neuropathies, Diabetes Mellitus, Type 2

What participants receive

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

High Frequency Spinal Cord StimulatorDevice
The SCS implant will follow standard clinical practice for these FDA approved indications. Two percutaneous leads will be placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator (trial phase) or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing will be performed to ensure electrical integrity. Patients with HF10 SCS will receive 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming will occur postoperatively and as needed based on patient feedback in standard clinic visits. .

Study groups in NCT03769675
Study group	Role	What they receive
Spinal Cord Stimulator Implant	Experimental	Spinal Cord Stimulator implant Receives: Device: High Frequency Spinal Cord Stimulator

What is being measured

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

Pain Assessment
Pain measurement using a Visual Analog Pain Scale by placing an X in the box to indicate the severity of pain from no pain to intolerable pain. The X in the box translates to a score of zero for no pain and increases by an additional 0.5 up to a high score of 10 which would be intolerable pain.
Measured: Baseline, 12 months
Neuropathy Symptoms and Change (NSC) Score
Validated questionnaire that evaluates change in neuropathy symptoms, including symptoms of weakness, sensory symptoms, and autonomic symptoms. Answers to questionnaire are yes/no and if yes, then degree of severity is evaluated with a plus one(slight), plus two (moderate) and plus three (severe). Questionnaire screens the presence and severity of diabetic peripheral neuropathy. Change in severity of symptoms are compared over time. Total scores range from 0 - 114, lower scores reflect no neuropathy symptoms, higher scores reflect more neuropathy symptoms.
Measured: baseline, 12 months
Oswestry Disability Index
Questionnaire examines perceived level of disability in 10 everyday activities of daily living including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The 6 statements are scored from 0 to 5 scale, zero meaning no disability. The final score ranges from 0-100 with a score of 0-20 equals minimal disability, 21-40 equals moderate disability, 41-60 equals severe disability, 61-80 equals crippled and 81-100 equals bed-bound.
Measured: Baseline, 12 months
Neuropathy Impairment Score (NIS)
Subject's scores neuropathic deficits using a scale of 0-4 (zero=normal, 4=paralysis) to measure muscle weakness. The NIS score is a measure of neurologic impairment. The NIS Score has a range of 0 to 244. Lower scores indicate higher function, higher scores indicate lower function.
Measured: Baseline, 12 months
Lower Limb Function Test
Test for lower limb function in which the subject will need to walk on toes, walk on heels, and arise from kneeled position, each test is marked as not applicable, normal or abnormal. The examination assesses each component for the left and right side separately. If the test is normal, it is given a score of 0, and if it is abnormal, a score of 1. Not applicable scores a zero. Total scores range 0-6. Therefore, the maximum score of 6 indicates abnormality in all 3 components bilaterally and a minimum score of 0 indicates a normal result for all 3 components bilaterally.
Measured: Baseline, 12 months
Modified Leads Assessment of Neuropathic Symptoms and Signs
Questionnaire to identify and analyze pain by answering yes/no which translates to scores from 0-24. A score of 12 or more suggests pain of predominantly neuropathic origin.
Measured: baseline, 12 months
Positive Pain
Numeric Rating Scale used to assess pain from a scale of 0 (no pain) to 10 (worst possible pain)
Measured: baseline, 12 months

Secondary outcomes (8)

Patient Health Questionnaire
Screens for the presence and severity of depression with 9 questions in a scale of 0-3. Zero=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Total score range 0 - 27. A total score of 0-4=minimal depression, 5-9=mild depression, 10-14=moderate depression, 15-19=moderately severe depression, 20-27=severe depression
Measured: Baseline, 12 months
Height
Subjects calculated height in centimeters.
Measured: Baseline, 12 months
Weight
Subjects calculated weight in kilograms
Measured: Baseline, 12 months
Body Mass Index (BMI)
Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions)
Measured: Baseline, 12 months
Hemoglobin A1c
Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin
Measured: Baseline, 12 months
Forearm Sweat Volume Quantitative Axon Reflex Sweat Test (Q-SWEAT)
Test that measures the rate and volume of sweat to determine the severity and pattern of autonomic disorders. As measured by µL/cm²
Measured: baseline, 12 months
Proximal Leg Laser Doppler Flowmetry (LDF)
Laser Doppler velocimetry is used in hemodynamics research as a technique to partially quantify blood flow in human tissues such as skin. Within the clinical environment, the technology is often referred to as laser Doppler flowmetry (LDF). As measured in perfusion units (p.u.)
Measured: Baseline, 12 months
Extensor Digitorum Brevis Muscle Nerve Conduction
A nerve conduction study (NCS) is a medical diagnostic test commonly used to evaluate the function, especially the ability of electrical conduction, of the motor and sensory nerves of the human body. As measured by amplitude (AMP) milliamp (mA)
Measured: Baseline, 12 months

Timeline

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

20 Nov 201815 Apr 2022

First posted7 Dec 2018
Study start20 Nov 2018
Primary completion15 Apr 2022
Study completion15 Apr 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 (1)Papers the sponsor has linked to this study.
Other trials for Painful Diabetic NeuropathyStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03769675
Sponsor's protocol ID: 17-004317
Status last verified: Apr 2023
First submitted: 20 Nov 2018
Last updated: 11 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Kissoon NR, LeMahieu AM, Stoltenberg AD, Bendel MA, Lamer TJ, Watson JC, Sletten DM, Singer W. Quantitative assessment of painful diabetic peripheral neuropathy after high-frequency spinal cord stimulation: a pilot study. Pain Med. 2023 Oct 13;24(Suppl 2):S41-S47. doi: 10.1093/pm/pnad087.
PubMed 37833046

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

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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 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation: (QUANT) HF10 Study
ClinicalTrials.gov ID: NCT03769675
Acronym / sponsor ID: 17-004317
Conditions: Painful Diabetic Neuropathy
Keywords: spinal cord stimulation, type 2 diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 20 Nov 2018 (actual)
Primary completion: 15 Apr 2022 (actual)
Study completion: 15 Apr 2022 (actual)
First posted: 7 Dec 2018 (actual)
Results: Posted 11 Apr 2023

Clinical summary

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

Detailed description

The purpose of this research is to gather information on the effect of high frequency spinal cord stimulation (HF10) on nerve function with a spinal cord stimulator.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Spinal Cord Stimulator Implant	Experimental	Device: High Frequency Spinal Cord StimulatorSpinal Cord Stimulator implant

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Type 2 diabetes mellitus
Refractory predominantly lower extremity neuropathic pain for > 1 year
Presence of length dependent peripheral neuropathy on sudomotor testing
Completed spinal cord stimulation trial with 40% or greater pain reduction from baseline
Failed medication trials or contraindication to gabapentin medications (gabapentin, pregabalin) and/or serotonin/norepinephrine reuptake inhibitors (tricyclic antidepressant (TCA) or duloxetine or venlafaxine)

Key exclusion criteria (11 listed)

Severe Autonomic Neuropathy as measured by the composite autonomic scoring scale (10 point scale) with a score ≥ 7
History of sympathectomy
Uncontrolled arterial hypertension (Systolic Blood Pressure >160)
Baseline Foot TcPO2 < 10 mmHg to exclude patients with severe peripheral arterial disease
Hemoglobin A1c > 8%

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
High Frequency Spinal Cord StimulatorThe SCS implant will follow standard clinical practice for these FDA approved indications. Two percutaneous leads will be placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator (trial phase) or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing will be performed to ensure electrical integrity. Patients with HF10 SCS will receive 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming will occur postoperatively and as needed based on patient feedback in standard clinic visits. .	Device	Spinal Cord Stimulator Implant

Primary outcome

Pain Assessment
Time frame: Baseline, 12 months
Pain measurement using a Visual Analog Pain Scale by placing an X in the box to indicate the severity of pain from no pain to intolerable pain. The X in the box translates to a score of zero for no pain and increases by an additional 0.5 up to a high score of 10 which would be intolerable pain.
Neuropathy Symptoms and Change (NSC) Score
Time frame: baseline, 12 months
Validated questionnaire that evaluates change in neuropathy symptoms, including symptoms of weakness, sensory symptoms, and autonomic symptoms. Answers to questionnaire are yes/no and if yes, then degree of severity is evaluated with a plus one(slight), plus two (moderate) and plus three (severe). Questionnaire screens the presence and severity of diabetic peripheral neuropathy. Change in severity of symptoms are compared over time. Total scores range from 0 - 114, lower scores reflect no neuropathy symptoms, higher scores reflect more neuropathy symptoms.
Oswestry Disability Index
Time frame: Baseline, 12 months
Questionnaire examines perceived level of disability in 10 everyday activities of daily living including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The 6 statements are scored from 0 to 5 scale, zero meaning no disability. The final score ranges from 0-100 with a score of 0-20 equals minimal disability, 21-40 equals moderate disability, 41-60 equals severe disability, 61-80 equals crippled and 81-100 equals bed-bound.
Neuropathy Impairment Score (NIS)
Time frame: Baseline, 12 months
Subject's scores neuropathic deficits using a scale of 0-4 (zero=normal, 4=paralysis) to measure muscle weakness. The NIS score is a measure of neurologic impairment. The NIS Score has a range of 0 to 244. Lower scores indicate higher function, higher scores indicate lower function.
Lower Limb Function Test
Time frame: Baseline, 12 months
Test for lower limb function in which the subject will need to walk on toes, walk on heels, and arise from kneeled position, each test is marked as not applicable, normal or abnormal. The examination assesses each component for the left and right side separately. If the test is normal, it is given a score of 0, and if it is abnormal, a score of 1. Not applicable scores a zero. Total scores range 0-6. Therefore, the maximum score of 6 indicates abnormality in all 3 components bilaterally and a minimum score of 0 indicates a normal result for all 3 components bilaterally.
Modified Leads Assessment of Neuropathic Symptoms and Signs
Time frame: baseline, 12 months
Questionnaire to identify and analyze pain by answering yes/no which translates to scores from 0-24. A score of 12 or more suggests pain of predominantly neuropathic origin.
Positive Pain
Time frame: baseline, 12 months
Numeric Rating Scale used to assess pain from a scale of 0 (no pain) to 10 (worst possible pain)

8 secondary outcomes

Patient Health Questionnaire
Time frame: Baseline, 12 months
Height
Time frame: Baseline, 12 months
Weight
Time frame: Baseline, 12 months
Body Mass Index (BMI)
Time frame: Baseline, 12 months
Hemoglobin A1c
Time frame: Baseline, 12 months
Forearm Sweat Volume Quantitative Axon Reflex Sweat Test (Q-SWEAT)
Time frame: baseline, 12 months
Proximal Leg Laser Doppler Flowmetry (LDF)
Time frame: Baseline, 12 months
Extensor Digitorum Brevis Muscle Nerve Conduction
Time frame: Baseline, 12 months

Results and safety

Results posted to the registry on 11 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spinal Cord Stimulator Implant (SCS)	10	9

Primary outcome: Pain Assessment

Time frame: Baseline, 12 months. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Spinal Cord Stimulator Implant (SCS) n = 10
baseline	6.5 (5.0 to 8.0)
12 months	1.0 (1.0 to 3.0)

Population analysed: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.

Primary outcome: Neuropathy Symptoms and Change (NSC) Score

Time frame: baseline, 12 months. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Spinal Cord Stimulator Implant (SCS) n = 10
baseline	21.5 (16.0 to 28.0)
12 months	9.0 (6.0 to 12.0)

Population analysed: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.

Primary outcome: Oswestry Disability Index

Time frame: Baseline, 12 months. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Spinal Cord Stimulator Implant (SCS) n = 10
baseline	37.0 (28.0 to 56.0)
12 months	18.0 (12.0 to 40.0)

Population analysed: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.

Primary outcome: Neuropathy Impairment Score (NIS)

Time frame: Baseline, 12 months. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Spinal Cord Stimulator Implant (SCS) n = 10
baseline	15.0 (12.0 to 24.0)
12 months	13.0 (6.0 to 16.0)

Population analysed: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from baseline to end of study, approximately 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spinal Cord Stimulator Implant (SCS)	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37833046Kissoon NR, LeMahieu AM, Stoltenberg AD, Bendel MA, Lamer TJ, Watson JC, Sletten DM, Singer W. Quantitative assessment of painful diabetic peripheral neuropathy after high-frequency spinal cord stimulation: a pilot study. Pain Med. 2023 Oct 13;24(Suppl 2):S41-S47. doi: 10.1093/pm/pnad087.
Mayo Clinic Clinical TrialsLink provided by the sponsor.

Related trials for Painful Diabetic Neuropathy

Recruiting
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.

Narayan R Kissoon principal investigator

Mayo Clinic

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

Questions about this trial

What is this clinical trial studying?

A study testing High Frequency Spinal Cord Stimulator in people with Painful Diabetic Neuropathy, run by Mayo Clinic at 1 site 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 7 inclusion and 11 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 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 11 Apr 2023). 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?

Pain Assessment (time frame: Baseline, 12 months). The study lists 7 primary outcomes in all. 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 NCT03769675, which also lists 1 linked publication.

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 11 Apr 2023.