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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Stimulator Implant | Experimental | Spinal Cord Stimulator implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Frequency Spinal Cord Stimulator | Device | 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. . |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Baseline, 12 months |
| Lower Limb Function Test |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Narayan R Kissoon | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37833046 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Cord Stimulator Implant (SCS) | Spinal Cord Stimulator implant High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Spinal Cord Stimulator Implant (SCS) | Spinal Cord Stimulator implant High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 12 months |
|
Adverse Events were collected from baseline to end of study, approximately 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spinal Cord Stimulator Implant (SCS) | Spinal Cord Stimulator implant High Frequency Spinal Cord Stimulator: The SCS implant followed standard clinical practice for FDA approved indications: Two percutaneous leads were placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing was performed to ensure electrical integrity. Patients with HF10 SCS received 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming occurred postoperatively and as needed based on patient feedback in standard clinic visits. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Narayan R. Kissoon, M.D. | Mayo Clinic | 507-284-4961 | Kissoon.Narayan@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2020 | Mar 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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|
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. |
| 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. | baseline, 12 months |
| Positive Pain | Numeric Rating Scale used to assess pain from a scale of 0 (no pain) to 10 (worst possible pain) | baseline, 12 months |
| Height | Subjects calculated height in centimeters. | Baseline, 12 months |
| Weight | Subjects calculated weight in kilograms | 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) | 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 | 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 | 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.) | 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) | Baseline, 12 months |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | score on a scale | baseline, 12 months |
|
|
|
| Primary | 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. | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 12 months |
|
|
|
| Primary | 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. | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 12 months |
|
|
|
| Primary | 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. | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 12 months |
|
|
|
| Primary | 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. | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | score on a scale | baseline, 12 months |
|
|
|
| Primary | Positive Pain | Numeric Rating Scale used to assess pain from a scale of 0 (no pain) to 10 (worst possible pain) | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | score on a scale | baseline, 12 months |
|
|
|
| Secondary | 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 | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 12 months |
|
|
|
| Secondary | Height | Subjects calculated height in centimeters. | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | cm | Baseline, 12 months |
|
|
|
| Secondary | Weight | Subjects calculated weight in kilograms | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | kg | Baseline, 12 months |
|
|
|
| Secondary | 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) | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | kg/m^2 | Baseline, 12 months |
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| Secondary | 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 | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | percentage of glycated hemoglobin | Baseline, 12 months |
|
|
|
| Secondary | 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 | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | µL/cm² | baseline, 12 months |
|
|
|
| Secondary | 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.) | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | perfusion units (p.u.) | Baseline, 12 months |
|
|
|
| Secondary | 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) | Data was not collected or analyzed at 12 months for the one subject who did not complete the study. | Posted | Median | Inter-Quartile Range | AMP (mA) | Baseline, 12 months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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