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

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ClinicalTrials.gov Identifier: NCT02349646
Recruitment Status : Terminated
First Posted : January 29, 2015
Results First Posted : June 26, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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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

Condition or disease Intervention/treatment
Peripheral Neuropathy Device: Implantation with the commercially available Axium neurostimulator

Study Design
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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Market Cohort With the Commercially Available Spinal Modulation Neurostimulator System for the Management of Peripheral Neuropathy
Actual Study Start Date : April 25, 2013
Actual Primary Completion Date : October 24, 2016
Actual Study Completion Date : October 24, 2016

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Treated subjects
All subjects recruited and treated with the Axium neurostimulator
 Device: Implantation with the commercially available Axium neurostimulator


Outcome Measures
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Primary Outcome Measures :
  1. Change in Pain Intensity for Overall Pain From Pre-treatment Baseline [ Time Frame: 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).

  2. Percentage of Subjects With at Least 50% Pain Reduction [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Peripheral Neuropathy Patients
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02349646


Locations
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Germany
Heinrich Heine Universität Düsseldorf
Düsseldorf, Germany, 40225
Sponsors and Collaborators
Abbott Medical Devices
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02349646    
Other Study ID Numbers: 10-SMI-2012
First Posted: January 29, 2015    Key Record Dates
Results First Posted: June 26, 2018
Last Update Posted: October 16, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases