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

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ClinicalTrials.gov Identifier: NCT02250469
Recruitment Status : Terminated
First Posted : September 26, 2014
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : September 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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



Primary Outcome Measures :
  1. Specificity of Stimulation Induced Paresthesia [ Time Frame: 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

  2. Stability of Stimulation Induced Paresthesia [ Time Frame: 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

  3. Patient Interactions with System [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02250469


Locations
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Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: M W Hollmann, Prof AIDS Malignancy Consortium
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02250469    
Other Study ID Numbers: 12-SMI-2014
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Paresthesia
Chronic Pain
Pain
Neurologic Manifestations
Somatosensory Disorders
Sensation Disorders
Nervous System Diseases