Neuropathic PainPhase 4OPNCT00871819
Optimized Programming in Spinal Cord Stimulation (SCS) System
A Phase 4 study testing Precision Spinal Cord Stimulation (SCS) in people with Neuropathic Pain and Pain, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
The objective of this study is to evaluate extent, location, and perception of paresthesia as a function of anode/cathode configuration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain, Pain
- What is being tested?
- Precision Spinal Cord Stimulation (SCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be previously implanted with Precision SCS System (3-36 months post permanent implant) having 2 parallel percutaneous leads placed between T8-T10.
- Be implanted with Precision SCS System for the treatment of neuropathic pain of trunk and/or limbs
- Be 18 years of age or older
- Be extremely satisfied, very satisfied, or satisfied with SCS therapy for treatment of pain condition
- Be able to use pen tablet to document regions of paresthesia and pain
- Be able to lie in the supine position for 45 minutes at a minimum
Show all 11Show fewer
- Be able to verbally report qualitative and quantitative aspects of paresthesia sensations.
- Have a paresthesia threshold on a standard program below 4mA while in the supine position
- Have at minimum the upper contact of one lead below T8 and the lower contact above T11 vertebral levels
- Be willing and able to comply with study-related procedure
- Agree to study requirements and provides written Informed Consent
Who cannot join
- Unable to read, write, speak, and understand English
- Currently pregnant or planning to become pregnant during the course of the study
- Have negative finding in any of the pre-screening and screening requirements
- Upon fluoroscopy, location of both leads is identified to be outside T8-T10 vertebral levels
- Unable to perceive the sensation of paresthesia associated with stimulation in the trunk and/or lower extremities
- Have a drug pump and/or a non-Precision neurostimulation device (regardless of whether active or inactive)
- Have had any interventional pain procedure or surgeries (including Interlaminar epidural steroid injection, Transforaminal epidural steroid injection, Caudal epidural steroid injection, Selective nerve root block, Intraarticular lumbar facet injection, Sacroiliac joint injection, Piriformis muscle injection, Trochanteric bursa injection, Hip/knee joint injections, Medial branch block (innervates facet joint), Pulsed radiofrequency neurotomy medial branches, Pulsed radiofrequency dorsal root ganglion, Thermal (high temperature) radiofrequency neurotomy medial branches, Trigger point injections, and Botulinum toxin injections) involving the spine within the past 30 days
- Have any condition that is likely to confound evaluation of study endpoints. Conditions that may make paresthesia coverage variable over the course of the study include multiple sclerosis, partial spinal cord injury, diabetic peripheral neuropathy, peripheral vascular disease, scoliosis, deafferentation, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego Medical Center
San Diego, California, 92037
About this study
Official title: Optimized Programming in a Multiple-Independent Current Sources Spinal Cord Stimulation (SCS) System
The objective of this study is to evaluate extent, location, and perception of paresthesia as a function of anode/cathode configuration.
Read the detailed description
The clinical results from this study may help to validate predictions made by mathematical models of neurons that are activated by SCS and increase scientific knowledge about the way in which different programs relate to satisfactory outcomes, such that use of the model may help in the development of new products.
- Conditions
- Neuropathic Pain, Pain
- Being tested
- Precision Spinal Cord Stimulation (SCS)
- Keywords
- Spinal Cord Stimulation
- Medical subject headings
- Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Spinal Cord Stimulation (SCS)Device
Also called Precision Spinal Cord Stimulation System
Various SCS device programming parameters
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation Group | Other | Spinal Cord Stimulation (SCS) Treatment Group Receives: Device: Precision Spinal Cord Stimulation (SCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)
Measured: Immediately post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Kormylo, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871819
- Sponsor's protocol ID
- A2008
- Acronym
- OP
- Status last verified
- Nov 2013
- First submitted
- 27 Mar 2009
- Last updated
- 27 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Programming in a Multiple-Independent Current Sources Spinal Cord Stimulation (SCS) System
- ClinicalTrials.gov ID
- NCT00871819
- Acronym / sponsor ID
- OP / A2008
- Conditions
- Neuropathic Pain, Pain
- Keywords
- Spinal Cord Stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 30 Mar 2009 (estimated)
- Results
- Posted 4 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate extent, location, and perception of paresthesia as a function of anode/cathode configuration.
Detailed description
The clinical results from this study may help to validate predictions made by mathematical models of neurons that are activated by SCS and increase scientific knowledge about the way in which different programs relate to satisfactory outcomes, such that use of the model may help in the development of new products.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation Group | Other | Device: Precision Spinal Cord Stimulation (SCS)Spinal Cord Stimulation (SCS) Treatment Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be previously implanted with Precision SCS System (3-36 months post permanent implant) having 2 parallel percutaneous leads placed between T8-T10.
- Be implanted with Precision SCS System for the treatment of neuropathic pain of trunk and/or limbs
- Be 18 years of age or older
- Be extremely satisfied, very satisfied, or satisfied with SCS therapy for treatment of pain condition
- Be able to use pen tablet to document regions of paresthesia and pain
Key exclusion criteria (8 listed)
- Unable to read, write, speak, and understand English
- Currently pregnant or planning to become pregnant during the course of the study
- Have negative finding in any of the pre-screening and screening requirements
- Upon fluoroscopy, location of both leads is identified to be outside T8-T10 vertebral levels
- Unable to perceive the sensation of paresthesia associated with stimulation in the trunk and/or lower extremities
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 |
|---|---|---|
| Precision Spinal Cord Stimulation (SCS)Also: Precision Spinal Cord Stimulation SystemVarious SCS device programming parameters | Device | Spinal Cord Stimulation Group |
Primary outcome
Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm)
Time frame: Immediately post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nicholas Kormylo, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Precision Spinal Cord Stimulation (SCS) in people with Neuropathic Pain and Pain, run by Boston Scientific Corporation at 1 site in United States.
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 11 inclusion and 8 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: finished, as of the sponsor's last update on 27 Nov 2013. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Correlation Coefficient Between Dorsal Root Paresthesia (Total Pixels Derived From Digital Drawing) at Maximum-comfortable Stimulation Level and Anode-cathode Separation Distance (mm) (time frame: Immediately post-procedure). 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 27 Nov 2013.