A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems
NCT ID: NCT02250469
Last Updated: 2022-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2014-09-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Axium SCS System
Implantation with the Axium Neurostimulator
Treatment with the Axium SCS system
Medtronic SCS System
Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System
Treatment with the Medtronic SCS System
Interventions
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Treatment with the Axium SCS system
Treatment with the Medtronic SCS System
Eligibility Criteria
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Inclusion 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
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
18 Years
75 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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M W Hollmann, Prof
Role: PRINCIPAL_INVESTIGATOR
AIDS Malignancy Consortium
Locations
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Academisch Medisch Centrum
Amsterdam, , Netherlands
Countries
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Other Identifiers
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12-SMI-2014
Identifier Type: -
Identifier Source: org_study_id
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