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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in United States

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.

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 groups in NCT03763708
Study groupRoleWhat they receive
Cohort 1: Low Energy - ContinuousExperimentalSubjects will be programmed to a specific frequency with a long pulse width at various amplitudes
Receives: Device: Spinal Cord Stimulation
Cohort 2: InterleavingExperimentalDetermine effects of delivering ping pulses combined with governed pulses while using separate sets of electrodes
Receives: Device: Spinal Cord Stimulation
Cohort 3: Cycling EvolveExperimentalSubjects will be programmed to high dose (HD) stimulation with various cycling parameters
Receives: Device: Spinal Cord Stimulation
Cohort 4: Low Energy Cycling 1ExperimentalEffects of decreased pulse widths with increased frequency - with and without cycling parameters
Receives: Device: Spinal Cord Stimulation
Cohort 5: Low Energy Cycling 2ExperimentalEffects 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)ExperimentalEffects of decreased frequency and therapy cycling parameters
Receives: Device: Spinal Cord Stimulation
Cohort 7: Super CycleExperimentalEffects of longer cycle duration
Receives: Device: Spinal Cord Stimulation
Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS)ExperimentalEffects of integrating Neuro Sense into DTM programming
Receives: Device: Spinal Cord Stimulation
Cohort 9: Diabetic Peripheral Neuropathy (DPN) FlowExperimentalCharacteristics 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  1. First posted4 Dec 2018
  2. Study start12 Dec 2018
  3. Primary completion13 Jan 2023
  4. 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

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

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