A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems

Chronic Pain Clinical Trial

— CHARACTER SCS  

Official title:

A Randomised Pilot Study to Assess differenCes in tHe Subjects' Experience of stimulAtion-Induced paRaesthesiA Between Two Different Spinal Cord sTimulation dEvices: the Axium® DoRsal Root Ganglion Stimulation System Versus the Prime Advanced Dorsal Column Stimulation System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02250469
• Other study ID #: 12-SMI-2014
• Status: Terminated
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: November 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subject is appropriate for SCS implantation according to standard criteria

2. Subject is >18 to <75 years old

3. Subject is able and willing to comply with the follow-up schedule and protocol

4. Subject has chronic (> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain

5. Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain

6. Subject is able to provide written informed consent

Exclusion Criteria:

1. Subject has no other exclusion criteria for SCS implantation according to standard criteria

2. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days

3. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months

4. Subject has participated in another clinical study within 30 days

5. Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy

Related Conditions & MeSH terms

• Chronic Pain
• Paresthesia

Intervention

Device:
• Treatment with the Axium SCS system

• Treatment with the Medtronic SCS System

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity of Stimulation Induced Paresthesia	A comparative analysis will be made between groups to determine the percentage of a patients painful and non-painful anatomy that is covered by stimulation induced paresthesia	3 Months post implantation
Primary	Stability of Stimulation Induced Paresthesia	A comparative analysis will be made between groups to determine any changes in the intensity of stimulation induced paresthesia in response to changes in body position	3 Months post implantation
Primary	Patient Interactions with System	A comparative analysis will be made between groups to determine the number of device interactions patients need to have on average, daily	3 Months post implantation