Chronic PainCHARACTER SCSNCT02250469
A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems
A study testing Treatment with the Axium SCS system and Treatment with the Medtronic SCS System in people with Chronic Pain, run by Abbott Medical Devices at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Treatment with the Axium SCS system and Treatment with the Medtronic SCS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Chronic Pain
- Being tested
- Treatment with the Axium SCS system, Treatment with the Medtronic SCS System
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with the Axium SCS systemDevice
Treatment with the Medtronic SCS SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Axium SCS System | Active comparator | Implantation with the Axium Neurostimulator Receives: Device: Treatment with the Axium SCS system |
| Medtronic SCS System | Active comparator | Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System Receives: Device: Treatment with the Medtronic SCS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 Months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M W Hollmann, Prof, Principal investigator, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250469
- Sponsor's protocol ID
- 12-SMI-2014
- Acronym
- CHARACTER SCS
- Status last verified
- Nov 2022
- First submitted
- 9 Sep 2014
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02250469
- Acronym / sponsor ID
- CHARACTER SCS / 12-SMI-2014
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axium SCS System | Active comparator | Device: Treatment with the Axium SCS systemImplantation with the Axium Neurostimulator |
| Medtronic SCS System | Active comparator | Device: Treatment with the Medtronic SCS SystemImplantation with the Medtronic Prime Advanced Dorsal Column Stimulation System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with the Axium SCS system | Device | Axium SCS System |
| Treatment with the Medtronic SCS System | Device | Medtronic SCS System |
Primary outcome
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
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
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M W Hollmann, Prof principal investigator
AIDS Malignancy Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with the Axium SCS system and Treatment with the Medtronic SCS System in people with Chronic Pain, run by Abbott Medical Devices at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity of Stimulation Induced Paresthesia (time frame: 3 Months post implantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.