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

NCT03769675 | Completed Results FDA Device

• 1 other identifier: 17-004317
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Painful Diabetic Neuropathy

Keywords

spinal cord stimulation; type 2 diabetes

Outcome Measures

Primary Outcomes (7)

• 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

  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

Secondary Outcomes (8)

• Patient Health Questionnaire

  Baseline, 12 months

• Height

  Baseline, 12 months

• Weight

  Baseline, 12 months

• Body Mass Index (BMI)

  Baseline, 12 months

• Hemoglobin A1c

  Baseline, 12 months

Study Arms (1)

Spinal Cord Stimulator Implant

EXPERIMENTAL

Spinal Cord Stimulator implant

Device: High Frequency Spinal Cord Stimulator

Interventions

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. .

Spinal Cord Stimulator Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 37833046 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Narayan R. Kissoon, M.D.
• Organization: Mayo Clinic

Kissoon.Narayan@mayo.edu

507-284-4961

Study Officials

• Narayan R Kissoon

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: December 7, 2018
• Study Start: November 20, 2018
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: April 11, 2023
• Results First Posted: April 11, 2023

Record last verified: 2023-04

Locations

US (1)