Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
100 participants
INTERVENTIONAL
2018-12-12
2023-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1: Low Energy - Continuous
Subjects will be programmed to a specific frequency with a long pulse width at various amplitudes
Spinal Cord Stimulation
Programming
Cohort 2: Interleaving
Determine effects of delivering ping pulses combined with governed pulses while using separate sets of electrodes
Spinal Cord Stimulation
Programming
Cohort 3: Cycling Evolve
Subjects will be programmed to high dose (HD) stimulation with various cycling parameters
Spinal Cord Stimulation
Programming
Cohort 4: Low Energy Cycling 1
Effects of decreased pulse widths with increased frequency - with and without cycling parameters
Spinal Cord Stimulation
Programming
Cohort 5: Low Energy Cycling 2
Effects of decreased pulse widths with increased frequency - with and without cycling parameters (different pulse widths and frequencies than Cohort 4)
Spinal Cord Stimulation
Programming
Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS)
Effects of decreased frequency and therapy cycling parameters
Spinal Cord Stimulation
Programming
Cohort 7: Super Cycle
Effects of longer cycle duration
Spinal Cord Stimulation
Programming
Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS)
Effects of integrating Neuro Sense into DTM programming
Spinal Cord Stimulation
Programming
Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow
Characteristics of vital signs in DPN participants
Spinal Cord Stimulation
Programming
Interventions
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Spinal Cord Stimulation
Programming
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Willing and able to provide signed and dated informed consent
4. Capable of comprehending and consenting in English
5. Willing and able to comply with all study procedures, including diary completion, and visits
6. Able to differentiate between pain associated with the indication for SCS implant and other types of pain
Exclusion Criteria
2. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
3. If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
4. Has untreated major psychiatric comorbidity
5. Has a non-rechargeable neurostimulator where the battery longevity is not able to be estimated with the battery longevity calculator
22 Years
ALL
No
Sponsors
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MedtronicNeuro
INDUSTRY
Responsible Party
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Locations
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Center for Pain and Supportive Care
Phoenix, Arizona, United States
Goodman Campbell Brain and Spine
Carmel, Indiana, United States
Drez One
Somerset, Kentucky, United States
Twin Cities Pain Clinic
Edina, Minnesota, United States
Regional Brain and Spine
Cape Girardeau, Missouri, United States
Carolinas Research Institute
Huntersville, North Carolina, United States
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, United States
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, United States
Northwest Pain Care
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MDT18036
Identifier Type: -
Identifier Source: org_study_id