Trial Outcomes & Findings for Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation (NCT NCT03769675)
NCT ID: NCT03769675
Last Updated: 2023-04-11
Results Overview
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.
COMPLETED
NA
10 participants
Baseline, 12 months
2023-04-11
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
|
9
|
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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|---|---|
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Age, Continuous
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55.0 years
n=10 Participants
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Sex/Gender, Customized
Female
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5 Participants
n=10 Participants
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Sex/Gender, Customized
Male
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4 Participants
n=10 Participants
|
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Sex/Gender, Customized
F-Transgender
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1 Participants
n=10 Participants
|
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Region of Enrollment
United States
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10 participants
n=10 Participants
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PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
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.
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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|---|---|
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Pain Assessment
baseline
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6.5 score on a scale
Interval 5.0 to 8.0
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Pain Assessment
12 months
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1.0 score on a scale
Interval 1.0 to 3.0
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PRIMARY outcome
Timeframe: baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
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.
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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|---|---|
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Neuropathy Symptoms and Change (NSC) Score
baseline
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21.5 score on a scale
Interval 16.0 to 28.0
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Neuropathy Symptoms and Change (NSC) Score
12 months
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9.0 score on a scale
Interval 6.0 to 12.0
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PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
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.
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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|---|---|
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Oswestry Disability Index
baseline
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37.0 score on a scale
Interval 28.0 to 56.0
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Oswestry Disability Index
12 months
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18.0 score on a scale
Interval 12.0 to 40.0
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PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
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.
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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|---|---|
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Neuropathy Impairment Score (NIS)
baseline
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15.0 score on a scale
Interval 12.0 to 24.0
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Neuropathy Impairment Score (NIS)
12 months
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13.0 score on a scale
Interval 6.0 to 16.0
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PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
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.
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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Lower Limb Function Test
Baseline
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1 score on a scale
Interval 0.0 to 2.0
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Lower Limb Function Test
12 months
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0 score on a scale
Interval 0.0 to 0.5
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PRIMARY outcome
Timeframe: baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
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.
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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|---|---|
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Modified Leads Assessment of Neuropathic Symptoms and Signs
baseline
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19.0 score on a scale
Interval 16.0 to 24.0
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Modified Leads Assessment of Neuropathic Symptoms and Signs
12 months
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17.0 score on a scale
Interval 11.0 to 22.0
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PRIMARY outcome
Timeframe: baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
Numeric Rating Scale used to assess pain from a scale of 0 (no pain) to 10 (worst possible pain)
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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|---|---|
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Positive Pain
baseline
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9.0 score on a scale
Interval 8.0 to 10.0
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Positive Pain
12 months
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3.0 score on a scale
Interval 2.0 to 4.0
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SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
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
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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Patient Health Questionnaire
baseline
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4.0 score on a scale
Interval 3.0 to 12.0
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Patient Health Questionnaire
12 months
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2.0 score on a scale
Interval 2.0 to 6.0
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SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
Subjects calculated height in centimeters.
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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|---|---|
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Height
baseline
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173 cm
Interval 160.0 to 185.0
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Height
12 months
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175 cm
Interval 159.0 to 186.0
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SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
Subjects calculated weight in kilograms
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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Weight
baseline
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97.0 kg
Interval 85.3 to 107.0
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Weight
12 months
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97.2 kg
Interval 92.9 to 123.0
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SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
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)
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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Body Mass Index (BMI)
baseline
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34.3 kg/m^2
Interval 31.2 to 36.1
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Body Mass Index (BMI)
12 weeks
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34.5 kg/m^2
Interval 31.2 to 37.3
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SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
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
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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Hemoglobin A1c
baseline
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7.3 percentage of glycated hemoglobin
Interval 6.1 to 7.7
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Hemoglobin A1c
12 weeks
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7.85 percentage of glycated hemoglobin
Interval 6.2 to 8.6
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SECONDARY outcome
Timeframe: baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
Test that measures the rate and volume of sweat to determine the severity and pattern of autonomic disorders. As measured by µL/cm²
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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|---|---|
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Forearm Sweat Volume Quantitative Axon Reflex Sweat Test (Q-SWEAT)
baseline
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1.3 µL/cm²
Interval 0.3 to 1.9
|
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Forearm Sweat Volume Quantitative Axon Reflex Sweat Test (Q-SWEAT)
12 months
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0.3 µL/cm²
Interval 0.2 to 1.6
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SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
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.)
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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|---|---|
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Proximal Leg Laser Doppler Flowmetry (LDF)
baseline
|
22.2 perfusion units (p.u.)
Interval 14.7 to 28.3
|
|
Proximal Leg Laser Doppler Flowmetry (LDF)
12 months
|
29.0 perfusion units (p.u.)
Interval 18.8 to 29.8
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SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: Data was not collected or analyzed at 12 months for the one subject who did not complete the study.
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)
Outcome measures
| Measure |
Spinal Cord Stimulator Implant (SCS)
n=10 Participants
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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|---|---|
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Extensor Digitorum Brevis Muscle Nerve Conduction
baseline
|
3.1 AMP (mA)
Interval 0.6 to 5.1
|
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Extensor Digitorum Brevis Muscle Nerve Conduction
12 months
|
1.0 AMP (mA)
Interval 0.5 to 5.0
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Adverse Events
Spinal Cord Stimulator Implant (SCS)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place