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

Not Applicable

Terminated

• Conditions: Chronic Pain
• Interventions: Device: Treatment with the Axium SCS system; Device: Treatment with the Medtronic SCS System

• Registration Number: NCT02250469
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-24
• Study First Posted: 2014-09-26
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Axium SCS System	Treatment with the Axium SCS system	Implantation with the Axium Neurostimulator
Medtronic SCS System	Treatment with the Medtronic SCS System	Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands