A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems
CHARACTER SCS
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Sep 2014
Typical duration for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 9, 2014
CompletedFirst Posted
Study publicly available on registry
September 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 9, 2022
November 1, 2022
2.3 years
September 9, 2014
November 8, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (2)
Axium SCS System
ACTIVE COMPARATORImplantation with the Axium Neurostimulator
Medtronic SCS System
ACTIVE COMPARATORImplantation with the Medtronic Prime Advanced Dorsal Column Stimulation System
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academisch Medisch Centrum
Amsterdam, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
M W Hollmann, Prof
AIDS Malignancy Consortium
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2014
First Posted
September 26, 2014
Study Start
September 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
November 9, 2022
Record last verified: 2022-11