A Post Market Cohort With the Spinal Modulation Neurostimulator System in Peripheral Neuropathy

A Post Market Cohort With the Commercially Available Spinal Modulation Neurostimulator System for the Management of Peripheral Neuropathy

10-SMI-2012 is a post market observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of peripheral neuropathy

Study Overview

• Status: Terminated
• Conditions: Peripheral Neuropathy
• Intervention / Treatment: Device: Implantation with the commercially available Axium neurostimulator

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Germany
  • Düsseldorf, Germany, 40225
    • Heinrich Heine Universität Düsseldorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Peripheral Neuropathy Patients

Description

Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Peripheral neuropathy for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Average baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
6. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
7. Subject is able to provide written informed consent

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target dorsal root ganglion within the past 3 months
5. Subject currently has an active implantable device including implanted cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects currently has an active infection
8. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
9. Subject has participated in another clinical investigation within 30 days that may confound the outcomes of the current study as determined by the investigator

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treated subjects; All subjects recruited and treated with the Axium neurostimulator	Device: Implantation with the commercially available Axium neurostimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With at Least 50% Pain Reduction	Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).	3, 6 and 12-Month Visits
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline	The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).	Baseline, 3, 6 and 12-Month Visits

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2013
• Primary Completion (Actual): October 24, 2016
• Study Completion (Actual): October 24, 2016

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: January 23, 2015
• First Posted (Estimate): January 29, 2015

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 4, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 10-SMI-2012