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

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02349646
• Other study ID #: 10-SMI-2012
• Status: Terminated
• Start date: April 25, 2013
• Est. completion date: October 24, 2016

Study information

• Verified date: October 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: October 24, 2016
• Est. primary completion date: October 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Device:
• Implantation with the commercially available Axium neurostimulator

Locations

Country	Name	City	State
Germany	Heinrich Heine Universität Düsseldorf	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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