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

Terminated

• Conditions: Peripheral Neuropathy
• Interventions: Device: Implantation with the commercially available Axium neurostimulator

• Registration Number: NCT02349646
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-25
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-23
• Study First Posted: 2015-01-29
• Primary Completion: 2016-10-24
• Study Completion: 2016-10-24
• Results First Submitted: 2017-09-14
• Results First Submitted QC: 2017-09-14
• Results First Posted: 2018-06-26
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-04
• Last Update Posted: 2019-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated subjects	Implantation with the commercially available Axium neurostimulator	All subjects recruited and treated with the Axium neurostimulator

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline	Baseline, 3, 6 and 12-Month Visits	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).
Percentage of Subjects With at Least 50% Pain Reduction	3, 6 and 12-Month Visits	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).

Trial Locations

Locations (1)

Heinrich Heine Universität Düsseldorf; 🇩🇪 Düsseldorf, Germany