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

Primary Purpose

Chronic Pain

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Treatment with the Axium SCS system
Treatment with the Medtronic SCS System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academisch Medisch Centrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Axium SCS System

Medtronic SCS System

Arm Description

Implantation with the Axium Neurostimulator

Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
September 9, 2014
Last Updated
November 8, 2022
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02250469
Brief Title
A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Axium SCS System
Arm Type
Active Comparator
Arm Description
Implantation with the Axium Neurostimulator
Arm Title
Medtronic SCS System
Arm Type
Active Comparator
Arm Description
Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System
Intervention Type
Device
Intervention Name(s)
Treatment with the Axium SCS system
Intervention Type
Device
Intervention Name(s)
Treatment with the Medtronic SCS System
Primary Outcome Measure Information:
Title
Specificity of Stimulation Induced Paresthesia
Description
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
Time Frame
3 Months post implantation
Title
Stability of Stimulation Induced Paresthesia
Description
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
Time Frame
3 Months post implantation
Title
Patient Interactions with System
Description
A comparative analysis will be made between groups to determine the number of device interactions patients need to have on average, daily
Time Frame
3 Months post implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is appropriate for SCS implantation according to standard criteria Subject is >18 to <75 years old Subject is able and willing to comply with the follow-up schedule and protocol Subject has chronic (> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain Subject is able to provide written informed consent Exclusion Criteria: Subject has no other exclusion criteria for SCS implantation according to standard criteria 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 DRG within the past 3 months Subject has participated in another clinical study within 30 days Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M W Hollmann, Prof
Organizational Affiliation
AIDS Malignancy Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academisch Medisch Centrum
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

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

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