- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02250469
A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems (CHARACTER SCS)
November 8, 2022 updated by: Abbott Medical Devices
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amsterdam, Netherlands
- Academisch Medisch Centrum
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Axium SCS System
Implantation with the Axium Neurostimulator
|
|
Active Comparator: Medtronic SCS System
Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 Months post implantation
|
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 Months post implantation
|
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
|
3 Months post implantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: M W Hollmann, Prof, AIDS Malignancy Consortium
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
September 9, 2014
First Submitted That Met QC Criteria
September 24, 2014
First Posted (Estimate)
September 26, 2014
Study Record Updates
Last Update Posted (Actual)
November 9, 2022
Last Update Submitted That Met QC Criteria
November 8, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-SMI-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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