Limb PainNCT03763708
SCS Research Study
A study testing Spinal Cord Stimulation in people with Limb Pain and Trunk Pain, run by MedtronicNeuro at 9 sites in United States.
Trial summary
To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Limb Pain, Trunk Pain
- What is being tested?
- Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesUnited States
- Study dates
- 12 Dec 2018to 13 Jan 2023
- Phase
- Interventional
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 22 years of age or older
- Implanted with a Medtronic rechargeable neurostimulation system, for a labeled indication, for at least 1 month and expected longevity of neurostimulator is at least 5 months
- Willing and able to provide signed and dated informed consent
- Capable of comprehending and consenting in English
- Willing and able to comply with all study procedures, including diary completion, and visits
- Able to differentiate between pain associated with the indication for SCS implant and other types of pain
Who cannot join
- Implanted with neurostimulation system for an off-label indication
- Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
- If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
- Has untreated major psychiatric comorbidity
- Has a non-rechargeable neurostimulator where the battery longevity is not able to be estimated with the battery longevity calculator
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Regional Brain and Spine
Cape Girardeau, Missouri, 63701
Goodman Campbell Brain and Spine
Carmel, Indiana, 46032
Twin Cities Pain Clinic
Edina, Minnesota, 55439
Carolinas Research Institute
Huntersville, North Carolina, 28078
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, 17601
Center for Pain and Supportive Care
Phoenix, Arizona, 85028
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, 15143
Drez One
Somerset, Kentucky, 42503
Northwest Pain Care
Spokane, Washington, 99201
About this study
Official title: Spinal Cord Stimulation Research Study
To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.
- Conditions
- Limb Pain, Trunk Pain
- Being tested
- Spinal Cord Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulationDevice
Programming
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Low Energy - Continuous | Experimental | Subjects will be programmed to a specific frequency with a long pulse width at various amplitudes Receives: Device: Spinal Cord Stimulation |
| Cohort 2: Interleaving | Experimental | Determine effects of delivering ping pulses combined with governed pulses while using separate sets of electrodes Receives: Device: Spinal Cord Stimulation |
| Cohort 3: Cycling Evolve | Experimental | Subjects will be programmed to high dose (HD) stimulation with various cycling parameters Receives: Device: Spinal Cord Stimulation |
| Cohort 4: Low Energy Cycling 1 | Experimental | Effects of decreased pulse widths with increased frequency - with and without cycling parameters Receives: Device: Spinal Cord Stimulation |
| Cohort 5: Low Energy Cycling 2 | Experimental | Effects of decreased pulse widths with increased frequency - with and without cycling parameters (different pulse widths and frequencies than Cohort 4) Receives: Device: Spinal Cord Stimulation |
| Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) | Experimental | Effects of decreased frequency and therapy cycling parameters Receives: Device: Spinal Cord Stimulation |
| Cohort 7: Super Cycle | Experimental | Effects of longer cycle duration Receives: Device: Spinal Cord Stimulation |
| Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) | Experimental | Effects of integrating Neuro Sense into DTM programming Receives: Device: Spinal Cord Stimulation |
| Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow | Experimental | Characteristics of vital signs in DPN participants Receives: Device: Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS) - Cohort 1
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Measured: Up to 5 months
Numeric Pain Rating Scale (NPRS) - Cohort 2
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Measured: Up to 2 months
Numeric Pain Rating Scale (NPRS) - Cohort 3
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Measured: Up to 3 months
Numeric Pain Rating Scale (NPRS) - Cohort 4
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Measured: Up to 5 months
Numeric Pain Rating Scale - Cohort 5
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Measured: Up to 5 months
Numeric Pain Rating Scale (NPRS) - Cohort 6
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Measured: Up to 7 months
Numeric Pain Rating Scale (NPRS) - Cohort 7
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Measured: Up to 8 months
Numeric Pain Rating Scale (NPRS) - Cohort 8
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Measured: Up to 0.5 months
Numeric Pain Rating Scale at Enrollment (NPRS) - Cohort 9
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start12 Dec 2018
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Why it stopped: Business temporarily suspended study January 2023 with intent to include additional cohorts in future. For business reasons, study terminated April 2024.
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 Limb PainStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763708
- Sponsor's protocol ID
- MDT18036
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2018
- Last updated
- 31 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation Research Study
- ClinicalTrials.gov ID
- NCT03763708
- Acronym / sponsor ID
- MDT18036
- Conditions
- Limb Pain, Trunk Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business temporarily suspended study January 2023 with intent to include additional cohorts in future. For business reasons, study terminated April 2024.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Posted 31 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Low Energy - Continuous | Experimental | Device: Spinal Cord StimulationSubjects will be programmed to a specific frequency with a long pulse width at various amplitudes |
| Cohort 2: Interleaving | Experimental | Device: Spinal Cord StimulationDetermine effects of delivering ping pulses combined with governed pulses while using separate sets of electrodes |
| Cohort 3: Cycling Evolve | Experimental | Device: Spinal Cord StimulationSubjects will be programmed to high dose (HD) stimulation with various cycling parameters |
| Cohort 4: Low Energy Cycling 1 | Experimental | Device: Spinal Cord StimulationEffects of decreased pulse widths with increased frequency - with and without cycling parameters |
| Cohort 5: Low Energy Cycling 2 | Experimental | Device: Spinal Cord StimulationEffects of decreased pulse widths with increased frequency - with and without cycling parameters (different pulse widths and frequencies than Cohort 4) |
| Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) | Experimental | Device: Spinal Cord StimulationEffects of decreased frequency and therapy cycling parameters |
| Cohort 7: Super Cycle | Experimental | Device: Spinal Cord StimulationEffects of longer cycle duration |
| Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) | Experimental | Device: Spinal Cord StimulationEffects of integrating Neuro Sense into DTM programming |
| Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow | Experimental | Device: Spinal Cord StimulationCharacteristics of vital signs in DPN participants |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 22 years of age or older
- Implanted with a Medtronic rechargeable neurostimulation system, for a labeled indication, for at least 1 month and expected longevity of neurostimulator is at least 5 months
- Willing and able to provide signed and dated informed consent
- Capable of comprehending and consenting in English
- Willing and able to comply with all study procedures, including diary completion, and visits
Key exclusion criteria (5 listed)
- Implanted with neurostimulation system for an off-label indication
- Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
- If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
- Has untreated major psychiatric comorbidity
- Has a non-rechargeable neurostimulator where the battery longevity is not able to be estimated with the battery longevity calculator
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 |
|---|---|---|
| Spinal Cord StimulationProgramming | Device | Cohort 1: Low Energy - Continuous, Cohort 2: Interleaving, Cohort 3: Cycling Evolve, Cohort 4: Low Energy Cycling 1, Cohort 5: Low Energy Cycling 2, Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS), Cohort 7: Super Cycle, Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS), Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow |
Primary outcome
Numeric Pain Rating Scale (NPRS) - Cohort 1
Time frame: Up to 5 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale (NPRS) - Cohort 2
Time frame: Up to 2 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale (NPRS) - Cohort 3
Time frame: Up to 3 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale (NPRS) - Cohort 4
Time frame: Up to 5 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale - Cohort 5
Time frame: Up to 5 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale (NPRS) - Cohort 6
Time frame: Up to 7 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale (NPRS) - Cohort 7
Time frame: Up to 8 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale (NPRS) - Cohort 8
Time frame: Up to 0.5 months
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Numeric Pain Rating Scale at Enrollment (NPRS) - Cohort 9
Time frame: Up to 1 month
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation in people with Limb Pain and Trunk Pain, run by MedtronicNeuro at 9 sites 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 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 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2024). 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?
Numeric Pain Rating Scale (NPRS) - Cohort 1 (time frame: Up to 5 months). The study lists 9 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 31 Dec 2024.