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

NCT02349646 | Terminated Results

• 1 other identifier: 10-SMI-2012
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Treated subjects

All subjects recruited and treated with the Axium neurostimulator

Device: Implantation with the commercially available Axium neurostimulator

Interventions

Implantation with the commercially available Axium neurostimulator DEVICE

Treated subjects

Eligibility Criteria

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

Study Population

Peripheral Neuropathy Patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Heinrich Heine Universität Düsseldorf

Düsseldorf, 40225, Germany

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Jennifer Duggan
• Organization: St. Jude Medical

jduggan@sjm.com

+32(0)27746827

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 29, 2015
• Study Start: April 25, 2013
• Primary Completion: October 24, 2016
• Study Completion: October 24, 2016
• Last Updated: October 16, 2019
• Results First Posted: June 26, 2018

Record last verified: 2019-10

Locations

DE (1)