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

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Terminated

CT.gov ID

NCT02250469

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: Treatment with the Axium SCS system Device: Treatment with the Medtronic SCS System	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Axium SCS System Implantation with the Axium Neurostimulator	Device: Treatment with the Axium SCS system
Active Comparator: Medtronic SCS System Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System	Device: Treatment with the Medtronic SCS System

Arm

Intervention/Treatment

Active Comparator: Axium SCS System

Implantation with the Axium Neurostimulator

Device: Treatment with the Axium SCS system

Active Comparator: Medtronic SCS System

Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System

Device: Treatment with the Medtronic SCS System

Outcome Measures

Primary Outcome Measures

Specificity of Stimulation Induced Paresthesia [3 Months post implantation]
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 [3 Months post implantation]
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 [3 Months post implantation]
A comparative analysis will be made between groups to determine the number of device interactions patients need to have on average, daily

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Academisch Medisch Centrum	Amsterdam		Netherlands

Sponsors and Collaborators

Abbott Medical Devices

Investigators

Principal Investigator: M W Hollmann, Prof, AIDS Malignancy Consortium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abbott Medical Devices

ClinicalTrials.gov Identifier:

NCT02250469

Other Study ID Numbers:

12-SMI-2014

First Posted:

Sep 26, 2014

Last Update Posted:

Jan 18, 2017

Last Verified:

Jan 1, 2017

Additional relevant MeSH terms:

Paresthesia

Chronic Pain

Study Results

No Results Posted as of Jan 18, 2017