Limb Pain, Trunk Pain
Conditions
Brief summary
To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.
Interventions
DEVICESpinal Cord Stimulation
Programming
Sponsors
MedtronicNeuro
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 22 years of age or older 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
1. Implanted with neurostimulation system for an off-label indication 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) - Cohort 1 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Some subjects participated in more than one cohort during the lifecycle of the study.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| Cohort 2: Interleaving Determine effects of delivering ping pulses combined with governed pulses while using separate sets of electrodes
Spinal Cord Stimulation: Programming | 10 |
| Cohort 3: Cycling Evolve Subjects will be programmed to high dose (HD) stimulation with various cycling parameters
Spinal Cord Stimulation: Programming | 4 |
| Cohort 4: Low Energy Cycling 1 Effects of decreased pulse widths with increased frequency - with and without cycling parameters
Spinal Cord Stimulation: Programming | 15 |
| 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 | 15 |
| 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 | 22 |
| Cohort 7: Super Cycle Effects of longer cycle duration
Spinal Cord Stimulation: Programming | 17 |
| Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Effects of integrating Neuro Sense into DTM programming
Spinal Cord Stimulation: Programming | 4 |
| Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Characteristics of vital signs in DPN participants
Spinal Cord Stimulation: Programming | 11 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1: Low Energy -Continuous | Withdrawal by Subject | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cohort 3: Cycling Evolve | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cohort 4: Low Energy Cycling 1 | Withdrawal by Subject | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Cohort 5: Low Energy Cycling 2 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Cohort 6: DTM-LE SCS | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Cohort 7: Super Cycle | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Cohort 7: Super Cycle | Screen Failure | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Cohort 7: Super Cycle | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 0 | 0 |
| Cohort 9: DPN Flow | Screen Failure | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Cohort 1: Low Energy - Continuous | Total | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Cohort 1: Low Energy - Continuous | 60.5 years STANDARD_DEVIATION 7.9 | 60.5 years STANDARD_DEVIATION 7.9 | — | — | — | — | — | — | — | — |
| Age, Continuous Cohort 2: Interleaving | — | 55.6 years STANDARD_DEVIATION 9.5 | 55.6 years STANDARD_DEVIATION 9.5 | — | — | — | — | — | — | — |
| Age, Continuous Cohort 3: Cycling Evolve | — | 59.4 years STANDARD_DEVIATION 9 | — | 59.4 years STANDARD_DEVIATION 9 | — | — | — | — | — | — |
| Age, Continuous Cohort 4: Low Energy Cycling 1 | — | 55.0 years STANDARD_DEVIATION 10.5 | — | — | 55.0 years STANDARD_DEVIATION 10.5 | — | — | — | — | — |
| Age, Continuous Cohort 5: Low Energy Cycling 2 | — | 55.2 years STANDARD_DEVIATION 12.3 | — | — | — | 55.2 years STANDARD_DEVIATION 12.3 | — | — | — | — |
| Age, Continuous Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) | — | 62.4 years STANDARD_DEVIATION 11.4 | — | — | — | — | 62.4 years STANDARD_DEVIATION 11.4 | — | — | — |
| Age, Continuous Cohort 7: Super Cycle | — | 64.9 years STANDARD_DEVIATION 8.7 | — | — | — | — | — | 64.9 years STANDARD_DEVIATION 8.7 | — | — |
| Age, Continuous Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) | — | 66.25 years STANDARD_DEVIATION 17.3 | — | — | — | — | — | — | 66.25 years STANDARD_DEVIATION 17.3 | — |
| Age, Continuous Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow | — | 55.9 years STANDARD_DEVIATION 16.37 | — | — | — | — | — | — | — | 55.9 years STANDARD_DEVIATION 16.37 |
| Days Since Implant to Enrollment | — | 13.9 days STANDARD_DEVIATION 3.8 | — | — | — | — | — | 13.9 days STANDARD_DEVIATION 3.8 | — | — |
| Ethnicity (NIH/OMB) Cohort 1: Low Energy - Continuous Hispanic or Latino | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 1: Low Energy - Continuous Not Hispanic or Latino | 15 Participants | 15 Participants | — | — | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 1: Low Energy - Continuous Unknown or Not Reported | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 2: Interleaving Hispanic or Latino | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 2: Interleaving Not Hispanic or Latino | — | 10 Participants | 10 Participants | — | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 2: Interleaving Unknown or Not Reported | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 3: Cycling Evolve Hispanic or Latino | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 3: Cycling Evolve Not Hispanic or Latino | — | 4 Participants | — | 4 Participants | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 3: Cycling Evolve Unknown or Not Reported | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 4: Low Energy Cycling 1 Hispanic or Latino | — | 0 Participants | — | — | 0 Participants | — | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 4: Low Energy Cycling 1 Not Hispanic or Latino | — | 13 Participants | — | — | 13 Participants | — | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 4: Low Energy Cycling 1 Unknown or Not Reported | — | 2 Participants | — | — | 2 Participants | — | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 5: Low Energy Cycling 2 Hispanic or Latino | — | 0 Participants | — | — | — | 0 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 5: Low Energy Cycling 2 Not Hispanic or Latino | — | 15 Participants | — | — | — | 15 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 5: Low Energy Cycling 2 Unknown or Not Reported | — | 0 Participants | — | — | — | 0 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Hispanic or Latino | — | 1 Participants | — | — | — | — | 1 Participants | — | — | — |
| Ethnicity (NIH/OMB) Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Not Hispanic or Latino | — | 21 Participants | — | — | — | — | 21 Participants | — | — | — |
| Ethnicity (NIH/OMB) Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Unknown or Not Reported | — | 0 Participants | — | — | — | — | 0 Participants | — | — | — |
| Ethnicity (NIH/OMB) Cohort 7: Super Cycle Hispanic or Latino | — | 0 Participants | — | — | — | — | — | 0 Participants | — | — |
| Ethnicity (NIH/OMB) Cohort 7: Super Cycle Not Hispanic or Latino | — | 17 Participants | — | — | — | — | — | 17 Participants | — | — |
| Ethnicity (NIH/OMB) Cohort 7: Super Cycle Unknown or Not Reported | — | 0 Participants | — | — | — | — | — | 0 Participants | — | — |
| Ethnicity (NIH/OMB) Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Hispanic or Latino | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Ethnicity (NIH/OMB) Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Not Hispanic or Latino | — | 4 Participants | — | — | — | — | — | — | 4 Participants | — |
| Ethnicity (NIH/OMB) Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Unknown or Not Reported | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Ethnicity (NIH/OMB) Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Hispanic or Latino | — | 0 Participants | — | — | — | — | — | — | — | 0 Participants |
| Ethnicity (NIH/OMB) Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Not Hispanic or Latino | — | 11 Participants | — | — | — | — | — | — | — | 11 Participants |
| Ethnicity (NIH/OMB) Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Unknown or Not Reported | — | 0 Participants | — | — | — | — | — | — | — | 0 Participants |
| Primary Indication Cohort 1: Low Energy - Continuous Arachnoiditis | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — |
| Primary Indication Cohort 1: Low Energy - Continuous Complex Regional Pain Syndrome | 2 Participants | 2 Participants | — | — | — | — | — | — | — | — |
| Primary Indication Cohort 1: Low Energy - Continuous Degenerative Disc Disease | 1 Participants | 1 Participants | — | — | — | — | — | — | — | — |
| Primary Indication Cohort 1: Low Energy - Continuous Epidural Fibrosis | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — |
| Primary Indication Cohort 1: Low Energy - Continuous Failed Back Surgery Syndrome | 3 Participants | 3 Participants | — | — | — | — | — | — | — | — |
| Primary Indication Cohort 1: Low Energy - Continuous Multiple Back Operations | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — |
| Primary Indication Cohort 1: Low Energy - Continuous Other | 1 Participants | 1 Participants | — | — | — | — | — | — | — | — |
| Primary Indication Cohort 1: Low Energy - Continuous Peripheral Causalgia | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — |
| Primary Indication Cohort 1: Low Energy - Continuous Postlaminectomy Pain | 6 Participants | 6 Participants | — | — | — | — | — | — | — | — |
| Primary Indication Cohort 1: Low Energy - Continuous Radicular Pain Syndrome | 2 Participants | 2 Participants | — | — | — | — | — | — | — | — |
| Primary Indication Cohort 1: Low Energy - Continuous Unsuccessful Disc Surgery | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — |
| Primary Indication Cohort 2: Interleaving Arachnoiditis | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — |
| Primary Indication Cohort 2: Interleaving Complex Regional Pain Syndrome | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — |
| Primary Indication Cohort 2: Interleaving Degenerative Disc Disease | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — |
| Primary Indication Cohort 2: Interleaving Epidural Fibrosis | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — |
| Primary Indication Cohort 2: Interleaving Failed Back Surgery Syndrome | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — |
| Primary Indication Cohort 2: Interleaving Multiple Back Operations | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — |
| Primary Indication Cohort 2: Interleaving Other | — | 1 Participants | 1 Participants | — | — | — | — | — | — | — |
| Primary Indication Cohort 2: Interleaving Peripheral Causalgia | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — |
| Primary Indication Cohort 2: Interleaving Postlaminectomy Pain | — | 5 Participants | 5 Participants | — | — | — | — | — | — | — |
| Primary Indication Cohort 2: Interleaving Radicular Pain Syndrome | — | 4 Participants | 4 Participants | — | — | — | — | — | — | — |
| Primary Indication Cohort 2: Interleaving Unsuccessful Disc Surgery | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — |
| Primary Indication Cohort 3: Cycling Evolve Arachnoiditis | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Primary Indication Cohort 3: Cycling Evolve Complex Regional Pain Syndrome | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Primary Indication Cohort 3: Cycling Evolve Degenerative Disc Disease | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Primary Indication Cohort 3: Cycling Evolve Epidural Fibrosis | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Primary Indication Cohort 3: Cycling Evolve Failed Back Surgery Syndrome | — | 1 Participants | — | 1 Participants | — | — | — | — | — | — |
| Primary Indication Cohort 3: Cycling Evolve Multiple Back Operations | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Primary Indication Cohort 3: Cycling Evolve Other | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Primary Indication Cohort 3: Cycling Evolve Peripheral Causalgia | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Primary Indication Cohort 3: Cycling Evolve Postlaminectomy Pain | — | 3 Participants | — | 3 Participants | — | — | — | — | — | — |
| Primary Indication Cohort 3: Cycling Evolve Radicular Pain Syndrome | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Primary Indication Cohort 3: Cycling Evolve Unsuccessful Disc Surgery | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Primary Indication Cohort 4: Low Energy Cycling 1 Arachnoiditis | — | 0 Participants | — | — | 0 Participants | — | — | — | — | — |
| Primary Indication Cohort 4: Low Energy Cycling 1 Complex Regional Pain Syndrome | — | 1 Participants | — | — | 1 Participants | — | — | — | — | — |
| Primary Indication Cohort 4: Low Energy Cycling 1 Degenerative Disc Disease | — | 3 Participants | — | — | 3 Participants | — | — | — | — | — |
| Primary Indication Cohort 4: Low Energy Cycling 1 Epidural Fibrosis | — | 0 Participants | — | — | 0 Participants | — | — | — | — | — |
| Primary Indication Cohort 4: Low Energy Cycling 1 Failed Back Surgery Syndrome | — | 0 Participants | — | — | 0 Participants | — | — | — | — | — |
| Primary Indication Cohort 4: Low Energy Cycling 1 Multiple Back Operations | — | 0 Participants | — | — | 0 Participants | — | — | — | — | — |
| Primary Indication Cohort 4: Low Energy Cycling 1 Other | — | 1 Participants | — | — | 1 Participants | — | — | — | — | — |
| Primary Indication Cohort 4: Low Energy Cycling 1 Peripheral Causalgia | — | 0 Participants | — | — | 0 Participants | — | — | — | — | — |
| Primary Indication Cohort 4: Low Energy Cycling 1 Postlaminectomy Pain | — | 9 Participants | — | — | 9 Participants | — | — | — | — | — |
| Primary Indication Cohort 4: Low Energy Cycling 1 Radicular Pain Syndrome | — | 1 Participants | — | — | 1 Participants | — | — | — | — | — |
| Primary Indication Cohort 4: Low Energy Cycling 1 Unsuccessful Disc Surgery | — | 0 Participants | — | — | 0 Participants | — | — | — | — | — |
| Primary Indication Cohort 5: Low Energy Cycling 2 Arachnoiditis | — | 0 Participants | — | — | — | 0 Participants | — | — | — | — |
| Primary Indication Cohort 5: Low Energy Cycling 2 Complex Regional Pain Syndrome | — | 0 Participants | — | — | — | 0 Participants | — | — | — | — |
| Primary Indication Cohort 5: Low Energy Cycling 2 Degenerative Disc Disease | — | 2 Participants | — | — | — | 2 Participants | — | — | — | — |
| Primary Indication Cohort 5: Low Energy Cycling 2 Epidural Fibrosis | — | 0 Participants | — | — | — | 0 Participants | — | — | — | — |
| Primary Indication Cohort 5: Low Energy Cycling 2 Failed Back Surgery Syndrome | — | 0 Participants | — | — | — | 0 Participants | — | — | — | — |
| Primary Indication Cohort 5: Low Energy Cycling 2 Multiple Back Operations | — | 0 Participants | — | — | — | 0 Participants | — | — | — | — |
| Primary Indication Cohort 5: Low Energy Cycling 2 Other | — | 0 Participants | — | — | — | 0 Participants | — | — | — | — |
| Primary Indication Cohort 5: Low Energy Cycling 2 Peripheral Causalgia | — | 0 Participants | — | — | — | 0 Participants | — | — | — | — |
| Primary Indication Cohort 5: Low Energy Cycling 2 Postlaminectomy Pain | — | 8 Participants | — | — | — | 8 Participants | — | — | — | — |
| Primary Indication Cohort 5: Low Energy Cycling 2 Radicular Pain Syndrome | — | 5 Participants | — | — | — | 5 Participants | — | — | — | — |
| Primary Indication Cohort 5: Low Energy Cycling 2 Unsuccessful Disc Surgery | — | 0 Participants | — | — | — | 0 Participants | — | — | — | — |
| Primary Indication Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Arachnoiditis | — | 0 Participants | — | — | — | — | 0 Participants | — | — | — |
| Primary Indication Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Complex Regional Pain Syndrome | — | 0 Participants | — | — | — | — | 0 Participants | — | — | — |
| Primary Indication Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Degenerative Disc Disease | — | 2 Participants | — | — | — | — | 2 Participants | — | — | — |
| Primary Indication Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Epidural Fibrosis | — | 0 Participants | — | — | — | — | 0 Participants | — | — | — |
| Primary Indication Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Failed Back Surgery Syndrome | — | 2 Participants | — | — | — | — | 2 Participants | — | — | — |
| Primary Indication Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Multiple Back Operations | — | 0 Participants | — | — | — | — | 0 Participants | — | — | — |
| Primary Indication Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Other | — | 0 Participants | — | — | — | — | 0 Participants | — | — | — |
| Primary Indication Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Peripheral Causalgia | — | 0 Participants | — | — | — | — | 0 Participants | — | — | — |
| Primary Indication Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Postlaminectomy Pain | — | 14 Participants | — | — | — | — | 14 Participants | — | — | — |
| Primary Indication Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Radicular Pain Syndrome | — | 4 Participants | — | — | — | — | 4 Participants | — | — | — |
| Primary Indication Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Unsuccessful Disc Surgery | — | 0 Participants | — | — | — | — | 0 Participants | — | — | — |
| Primary Indication Cohort 7: Super Cycle Arachnoiditis | — | 0 Participants | — | — | — | — | — | 0 Participants | — | — |
| Primary Indication Cohort 7: Super Cycle Complex Regional Pain Syndrome | — | 0 Participants | — | — | — | — | — | 0 Participants | — | — |
| Primary Indication Cohort 7: Super Cycle Degenerative Disc Disease | — | 1 Participants | — | — | — | — | — | 1 Participants | — | — |
| Primary Indication Cohort 7: Super Cycle Epidural Fibrosis | — | 0 Participants | — | — | — | — | — | 0 Participants | — | — |
| Primary Indication Cohort 7: Super Cycle Failed Back Surgery Syndrome | — | 2 Participants | — | — | — | — | — | 2 Participants | — | — |
| Primary Indication Cohort 7: Super Cycle Multiple Back Operations | — | 0 Participants | — | — | — | — | — | 0 Participants | — | — |
| Primary Indication Cohort 7: Super Cycle Other | — | 2 Participants | — | — | — | — | — | 2 Participants | — | — |
| Primary Indication Cohort 7: Super Cycle Peripheral Causalgia | — | 0 Participants | — | — | — | — | — | 0 Participants | — | — |
| Primary Indication Cohort 7: Super Cycle Postlaminectomy Pain | — | 9 Participants | — | — | — | — | — | 9 Participants | — | — |
| Primary Indication Cohort 7: Super Cycle Radicular Pain Syndrome | — | 3 Participants | — | — | — | — | — | 3 Participants | — | — |
| Primary Indication Cohort 7: Super Cycle Unsuccessful Disc Surgery | — | 0 Participants | — | — | — | — | — | 0 Participants | — | — |
| Primary Indication Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Arachnoiditis | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Primary Indication Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Complex Regional Pain Syndrome | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Primary Indication Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Degenerative Disc Disease | — | 1 Participants | — | — | — | — | — | — | 1 Participants | — |
| Primary Indication Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Epidural Fibrosis | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Primary Indication Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Failed Back Surgery Syndrome | — | 1 Participants | — | — | — | — | — | — | 1 Participants | — |
| Primary Indication Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Multiple Back Operations | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Primary Indication Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Other | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Primary Indication Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Peripheral Causalgia | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Primary Indication Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Postlaminectomy Pain | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Primary Indication Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Radicular Pain Syndrome | — | 2 Participants | — | — | — | — | — | — | 2 Participants | — |
| Primary Indication Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Unsuccessful Disc Surgery | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Primary Indication Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Arachnoiditis | — | 0 Participants | — | — | — | — | — | — | — | 0 Participants |
| Primary Indication Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Complex Regional Pain Syndrome | — | 2 Participants | — | — | — | — | — | — | — | 2 Participants |
| Primary Indication Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Degenerative Disc Disease | — | 0 Participants | — | — | — | — | — | — | — | 0 Participants |
| Primary Indication Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Epidural Fibrosis | — | 0 Participants | — | — | — | — | — | — | — | 0 Participants |
| Primary Indication Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Failed Back Surgery Syndrome | — | 0 Participants | — | — | — | — | — | — | — | 0 Participants |
| Primary Indication Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Multiple Back Operations | — | 0 Participants | — | — | — | — | — | — | — | 0 Participants |
| Primary Indication Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Other | — | 0 Participants | — | — | — | — | — | — | — | 0 Participants |
| Primary Indication Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Peripheral Causalgia | — | 0 Participants | — | — | — | — | — | — | — | 0 Participants |
| Primary Indication Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Postlaminectomy Pain | — | 8 Participants | — | — | — | — | — | — | — | 8 Participants |
| Primary Indication Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Radicular Pain Syndrome | — | 1 Participants | — | — | — | — | — | — | — | 1 Participants |
| Primary Indication Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Unsuccessful Disc Surgery | — | 0 Participants | — | — | — | — | — | — | — | 0 Participants |
| Race/Ethnicity, Customized Cohort 1: Low Energy - Continuous American Indian or Alaska Native | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 1: Low Energy - Continuous Asian | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 1: Low Energy - Continuous Black or African American | 1 Participants | 1 Participants | — | — | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 1: Low Energy - Continuous Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 1: Low Energy - Continuous Other | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 1: Low Energy - Continuous White | 14 Participants | 14 Participants | — | — | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 2: Interleaving American Indian or Alaska Native | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 2: Interleaving Asian | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 2: Interleaving Black or African American | — | 1 Participants | 1 Participants | — | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 2: Interleaving Native Hawaiian or Other Pacific Islander | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 2: Interleaving Other | — | 0 Participants | 0 Participants | — | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 2: Interleaving White | — | 9 Participants | 9 Participants | — | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 3: Cycling Evolve American Indian or Alaska Native | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 3: Cycling Evolve Asian | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 3: Cycling Evolve Black or African American | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 3: Cycling Evolve Native Hawaiian or Other Pacific Islander | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 3: Cycling Evolve Other | — | 0 Participants | — | 0 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 3: Cycling Evolve White | — | 4 Participants | — | 4 Participants | — | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 4: Low Energy Cycling 1 American Indian or Alaska Native | — | 1 Participants | — | — | 1 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 4: Low Energy Cycling 1 Asian | — | 0 Participants | — | — | 0 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 4: Low Energy Cycling 1 Black or African American | — | 3 Participants | — | — | 3 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 4: Low Energy Cycling 1 Native Hawaiian or Other Pacific Islander | — | 0 Participants | — | — | 0 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 4: Low Energy Cycling 1 Other | — | 0 Participants | — | — | 0 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 4: Low Energy Cycling 1 White | — | 11 Participants | — | — | 11 Participants | — | — | — | — | — |
| Race/Ethnicity, Customized Cohort 5: Low Energy Cycling 2 American Indian or Alaska Native | — | 0 Participants | — | — | — | 0 Participants | — | — | — | — |
| Race/Ethnicity, Customized Cohort 5: Low Energy Cycling 2 Asian | — | 0 Participants | — | — | — | 0 Participants | — | — | — | — |
| Race/Ethnicity, Customized Cohort 5: Low Energy Cycling 2 Black or African American | — | 1 Participants | — | — | — | 1 Participants | — | — | — | — |
| Race/Ethnicity, Customized Cohort 5: Low Energy Cycling 2 Native Hawaiian or Other Pacific Islander | — | 0 Participants | — | — | — | 0 Participants | — | — | — | — |
| Race/Ethnicity, Customized Cohort 5: Low Energy Cycling 2 Other | — | 0 Participants | — | — | — | 0 Participants | — | — | — | — |
| Race/Ethnicity, Customized Cohort 5: Low Energy Cycling 2 White | — | 14 Participants | — | — | — | 14 Participants | — | — | — | — |
| Race/Ethnicity, Customized Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) American Indian or Alaska Native | — | 0 Participants | — | — | — | — | 0 Participants | — | — | — |
| Race/Ethnicity, Customized Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Asian | — | 0 Participants | — | — | — | — | 0 Participants | — | — | — |
| Race/Ethnicity, Customized Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Black or African American | — | 0 Participants | — | — | — | — | 0 Participants | — | — | — |
| Race/Ethnicity, Customized Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Native Hawaiian or Other Pacific Islander | — | 0 Participants | — | — | — | — | 0 Participants | — | — | — |
| Race/Ethnicity, Customized Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Other | — | 0 Participants | — | — | — | — | 0 Participants | — | — | — |
| Race/Ethnicity, Customized Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) White | — | 22 Participants | — | — | — | — | 22 Participants | — | — | — |
| Race/Ethnicity, Customized Cohort 7: Super Cycle American Indian or Alaska Native | — | 0 Participants | — | — | — | — | — | 0 Participants | — | — |
| Race/Ethnicity, Customized Cohort 7: Super Cycle Asian | — | 0 Participants | — | — | — | — | — | 0 Participants | — | — |
| Race/Ethnicity, Customized Cohort 7: Super Cycle Black or African American | — | 1 Participants | — | — | — | — | — | 1 Participants | — | — |
| Race/Ethnicity, Customized Cohort 7: Super Cycle Native Hawaiian or Other Pacific Islander | — | 0 Participants | — | — | — | — | — | 0 Participants | — | — |
| Race/Ethnicity, Customized Cohort 7: Super Cycle Other | — | 0 Participants | — | — | — | — | — | 0 Participants | — | — |
| Race/Ethnicity, Customized Cohort 7: Super Cycle White | — | 16 Participants | — | — | — | — | — | 16 Participants | — | — |
| Race/Ethnicity, Customized Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) American Indian or Alaska Native | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Race/Ethnicity, Customized Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Asian | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Race/Ethnicity, Customized Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Black or African American | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Race/Ethnicity, Customized Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Native Hawaiian or Other Pacific Islander | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Race/Ethnicity, Customized Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Other | — | 0 Participants | — | — | — | — | — | — | 0 Participants | — |
| Race/Ethnicity, Customized Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) White | — | 4 Participants | — | — | — | — | — | — | 4 Participants | — |
| Race/Ethnicity, Customized Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow American Indian or Alaska Native | — | 0 Participants | — | — | — | — | — | — | — | 0 Participants |
| Race/Ethnicity, Customized Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Asian | — | 0 Participants | — | — | — | — | — | — | — | 0 Participants |
| Race/Ethnicity, Customized Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Black or African American | — | 1 Participants | — | — | — | — | — | — | — | 1 Participants |
| Race/Ethnicity, Customized Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Native Hawaiian or Other Pacific Islander | — | 0 Participants | — | — | — | — | — | — | — | 0 Participants |
| Race/Ethnicity, Customized Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Other | — | 0 Participants | — | — | — | — | — | — | — | 0 Participants |
| Race/Ethnicity, Customized Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow White | — | 10 Participants | — | — | — | — | — | — | — | 10 Participants |
| Region of Enrollment United States | 15 participants | 113 participants | 10 participants | 4 participants | 15 participants | 15 participants | 22 participants | 17 participants | 4 participants | 11 participants |
| Sex: Female, Male Cohort 1: Low Energy - Continuous Female | 8 Participants | 8 Participants | — | — | — | — | — | — | — | — |
| Sex: Female, Male Cohort 1: Low Energy - Continuous Male | 7 Participants | 7 Participants | — | — | — | — | — | — | — | — |
| Sex: Female, Male Cohort 2: Interleaving Female | — | 6 Participants | 6 Participants | — | — | — | — | — | — | — |
| Sex: Female, Male Cohort 2: Interleaving Male | — | 4 Participants | 4 Participants | — | — | — | — | — | — | — |
| Sex: Female, Male Cohort 3: Cycling Evolve Female | — | 2 Participants | — | 2 Participants | — | — | — | — | — | — |
| Sex: Female, Male Cohort 3: Cycling Evolve Male | — | 2 Participants | — | 2 Participants | — | — | — | — | — | — |
| Sex: Female, Male Cohort 4: Low Energy Cycling 1 Female | — | 5 Participants | — | — | 5 Participants | — | — | — | — | — |
| Sex: Female, Male Cohort 4: Low Energy Cycling 1 Male | — | 10 Participants | — | — | 10 Participants | — | — | — | — | — |
| Sex: Female, Male Cohort 5: Low Energy Cycling 2 Female | — | 7 Participants | — | — | — | 7 Participants | — | — | — | — |
| Sex: Female, Male Cohort 5: Low Energy Cycling 2 Male | — | 8 Participants | — | — | — | 8 Participants | — | — | — | — |
| Sex: Female, Male Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Female | — | 13 Participants | — | — | — | — | 13 Participants | — | — | — |
| Sex: Female, Male Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) Male | — | 9 Participants | — | — | — | — | 9 Participants | — | — | — |
| Sex: Female, Male Cohort 7: Super Cycle Female | — | 10 Participants | — | — | — | — | — | 10 Participants | — | — |
| Sex: Female, Male Cohort 7: Super Cycle Male | — | 7 Participants | — | — | — | — | — | 7 Participants | — | — |
| Sex: Female, Male Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Female | — | 1 Participants | — | — | — | — | — | — | 1 Participants | — |
| Sex: Female, Male Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) Male | — | 3 Participants | — | — | — | — | — | — | 3 Participants | — |
| Sex: Female, Male Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Female | — | 6 Participants | — | — | — | — | — | — | — | 6 Participants |
| Sex: Female, Male Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow Male | — | 5 Participants | — | — | — | — | — | — | — | 5 Participants |
| Years Since Implant to Enrollment Cohort 1: Low Energy - Continuous | 0.9 years STANDARD_DEVIATION 1 | 0.9 years STANDARD_DEVIATION 1 | — | — | — | — | — | — | — | — |
| Years Since Implant to Enrollment Cohort 2: Interleaving | — | 0.8 years STANDARD_DEVIATION 0.4 | 0.8 years STANDARD_DEVIATION 0.4 | — | — | — | — | — | — | — |
| Years Since Implant to Enrollment Cohort 3: Cycling Evolve | — | 1.1 years STANDARD_DEVIATION 0.5 | — | 1.1 years STANDARD_DEVIATION 0.5 | — | — | — | — | — | — |
| Years Since Implant to Enrollment Cohort 4: Low Energy Cycling 1 | — | 1.1 years STANDARD_DEVIATION 0.5 | — | — | 1.1 years STANDARD_DEVIATION 0.5 | — | — | — | — | — |
| Years Since Implant to Enrollment Cohort 5: Low Energy Cycling 2 | — | 1.1 years STANDARD_DEVIATION 0.5 | — | — | — | 1.1 years STANDARD_DEVIATION 0.5 | — | — | — | — |
| Years Since Implant to Enrollment Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) | — | 1.6 years STANDARD_DEVIATION 1 | — | — | — | — | 1.6 years STANDARD_DEVIATION 1 | — | — | — |
| Years Since Implant to Enrollment Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) | — | 0.83 years STANDARD_DEVIATION 0.4 | — | — | — | — | — | — | 0.83 years STANDARD_DEVIATION 0.4 | — |
| Years Since Implant to Enrollment Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow | — | 4.5 years STANDARD_DEVIATION 4.37 | — | — | — | — | — | — | — | 4.5 years STANDARD_DEVIATION 4.37 |
| Years Since Onset of Chronic Pain Cohort 1: Low Energy - Continuous | 13.7 years STANDARD_DEVIATION 9.8 | 13.7 years STANDARD_DEVIATION 9.8 | — | — | — | — | — | — | — | — |
| Years Since Onset of Chronic Pain Cohort 2: Interleaving | — | 21.5 years STANDARD_DEVIATION 15.8 | 21.5 years STANDARD_DEVIATION 15.8 | — | — | — | — | — | — | — |
| Years Since Onset of Chronic Pain Cohort 3: Cycling Evolve | — | 27.0 years STANDARD_DEVIATION 18.7 | — | 27.0 years STANDARD_DEVIATION 18.7 | — | — | — | — | — | — |
| Years Since Onset of Chronic Pain Cohort 4: Low Energy Cycling 1 | — | 20.7 years STANDARD_DEVIATION 16.4 | — | — | 20.7 years STANDARD_DEVIATION 16.4 | — | — | — | — | — |
| Years Since Onset of Chronic Pain Cohort 5: Low Energy Cycling 2 | — | 16.5 years STANDARD_DEVIATION 8.4 | — | — | — | 16.5 years STANDARD_DEVIATION 8.4 | — | — | — | — |
| Years Since Onset of Chronic Pain Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) | — | 20.6 years STANDARD_DEVIATION 12.4 | — | — | — | — | 20.6 years STANDARD_DEVIATION 12.4 | — | — | — |
| Years Since Onset of Chronic Pain Cohort 7: Super Cycle | — | 9.5 years STANDARD_DEVIATION 9.1 | — | — | — | — | — | 9.5 years STANDARD_DEVIATION 9.1 | — | — |
| Years Since Onset of Chronic Pain Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) | — | 4.25 years STANDARD_DEVIATION 2.6 | — | — | — | — | — | — | 4.25 years STANDARD_DEVIATION 2.6 | — |
| Years Since Onset of Chronic Pain Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow | — | 17.8 years STANDARD_DEVIATION 17.17 | — | — | — | — | — | — | — | 17.8 years STANDARD_DEVIATION 17.17 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 10 | 0 / 4 | 0 / 15 | 0 / 15 | 0 / 22 | 0 / 17 | 0 / 4 | 0 / 11 |
| other Total, other adverse events | 5 / 15 | 1 / 10 | 0 / 4 | 4 / 15 | 2 / 15 | 3 / 22 | 3 / 17 | 0 / 4 | 0 / 11 |
| serious Total, serious adverse events | 0 / 15 | 0 / 10 | 0 / 4 | 0 / 15 | 0 / 15 | 0 / 22 | 0 / 17 | 0 / 4 | 0 / 11 |
Outcome results
Primary
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.
Time frame: Up to 1 month
Population: Number analyzed refers to patients with measure available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale at Enrollment (NPRS) - Cohort 9 | 3.8 score on a scale | Standard Deviation 2.25 |
Primary
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.
Time frame: Up to 5 months
Population: Number analyzed refers to patients with measure available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale - Cohort 5 | Enrollment | 4.8 score on a scale | Standard Deviation 2.5 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale - Cohort 5 | Low Energy 1, cycling off (Period 1) | 5.0 score on a scale | Standard Deviation 1.9 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale - Cohort 5 | Low Energy 1, cycling ON (Period 2) | 5.0 score on a scale | Standard Deviation 2 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale - Cohort 5 | Low Energy 1, cycling ON (Period 3) | 5.2 score on a scale | Standard Deviation 2.3 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale - Cohort 5 | Low Energy 2, cycling off (Period 4) | 4.2 score on a scale | Standard Deviation 2 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale - Cohort 5 | Low Energy 2, cycling ON (Period 5) | 4.7 score on a scale | Standard Deviation 2.2 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale - Cohort 5 | Low Energy 2, cycling ON (Period 6) | 4.5 score on a scale | Standard Deviation 1.8 |
Primary
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.
Time frame: Up to 5 months
Population: Number analyzed refers to patients with measure available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 1 | Enrollment | 5.2 score on a scale | Standard Deviation 2.5 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 1 | Comfortable amplitude (Period 1) | 4.9 score on a scale | Standard Deviation 2.3 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 1 | 80% comfortable amplitude (Period 2) | 5.1 score on a scale | Standard Deviation 2.3 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 1 | 60% comfortable amplitude (Period 3) | 4.9 score on a scale | Standard Deviation 2.1 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 1 | 40% comfortable amplitude (Period 4) | 4.6 score on a scale | Standard Deviation 2.1 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 1 | 20% comfortable amplitude (Period 5) | 4.7 score on a scale | Standard Deviation 2 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 1 | 0 mA/V (Period 6) | 4.7 score on a scale | Standard Deviation 1.9 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 1 | Comfortable amplitude with 25% duty cycle (Period 7) | 4.3 score on a scale | Standard Deviation 2.3 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 1 | The best amplitude and cycling enabling 5 years on a PC (Period 8) | 4.7 score on a scale | Standard Deviation 1.9 |
Primary
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.
Time frame: Up to 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 2 | Enrollment | 4.6 score on a scale | Standard Deviation 2.46 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 2 | Follow-up (HD) | 4.3 score on a scale | Standard Deviation 2.48 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 2 | Follow-up (LD) | 5.5 score on a scale | Standard Deviation 1.33 |
Primary
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.
Time frame: Up to 3 months
Population: Number analyzed refers to patients with measure available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 3 | Enrollment | 4.0 score on a scale | Standard Deviation 2.6 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 3 | Follow Up 1 (Came in at Cycling Off) | 3.9 score on a scale | Standard Deviation 2.4 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 3 | Follow Up 2 (Came in at Cycling ON) | 4.9 score on a scale | Standard Deviation 2.2 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 3 | Follow Up 3 (Came in at Cycling ON) | 4.5 score on a scale | Standard Deviation 2.1 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 3 | Follow Up 4 (Came in at Cycling ON) | 4.7 score on a scale | Standard Deviation 2.5 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 3 | Follow Up 5 (Came in at Cycling ON) | 4.2 score on a scale | Standard Deviation 2.4 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 3 | Final Study Visit (Came in at Cycling ON) | 3.2 score on a scale | Standard Deviation 2.2 |
Primary
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.
Time frame: Up to 5 months
Population: Number analyzed refers to patients with measure available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 4 | Enrollment | 3.9 score on a scale | Standard Deviation 3 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 4 | Low Energy 1, cycling off (Period 1) | 4.9 score on a scale | Standard Deviation 2.4 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 4 | Low Energy 1, cycling ON (Period 2) | 5.1 score on a scale | Standard Deviation 2 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 4 | Low Energy 1, cycling ON (Period 3) | 5.6 score on a scale | Standard Deviation 2.1 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 4 | Low Energy 2, cycling off (Period 4) | 4.7 score on a scale | Standard Deviation 2.3 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 4 | Low Energy 2, cycling ON (Period 5) | 4.9 score on a scale | Standard Deviation 2.3 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 4 | Low Energy 2, cycling ON (Period 6) | 5.1 score on a scale | Standard Deviation 2.4 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 4 | Low Energy 2, cycling ON (Period 7) | 5.3 score on a scale | Standard Deviation 2.4 |
Primary
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.
Time frame: Up to 7 months
Population: Number analyzed refers to patients with measure available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 6 | Enrollment | 3.5 score on a scale | Standard Deviation 1.8 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 6 | Washout (Follow-up 1) | 5.6 score on a scale | Standard Deviation 2 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 6 | DTM-LE Continuous (Follow-up 2) | 4.3 score on a scale | Standard Deviation 2.1 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 6 | DTM-LE Duty Cycle Enabled* (Follow-up 3) | 4.4 score on a scale | Standard Deviation 2.1 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 6 | 2-Week Follow-up (Follow-up 4) | 3.7 score on a scale | Standard Deviation 1.6 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 6 | 1-Month Follow-up (Follow-up 5) | 3.8 score on a scale | Standard Deviation 1.7 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 6 | 2-Month Follow-up (Follow-up 6) | 4.2 score on a scale | Standard Deviation 1.1 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 6 | 3-Month Follow-up (Final Study Visit) | 4.0 score on a scale | Standard Deviation 1.4 |
Primary
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.
Time frame: Up to 8 months
Population: Number analyzed refers to patients with measure available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 7 | Pre-SCS Pain Score | 8.5 score on a scale | Standard Deviation 1.4 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 7 | Enrollment | 5.5 score on a scale | Standard Deviation 3 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 7 | Optimization Visit 1 (Follow Up 1) | 6.1 score on a scale | Standard Deviation 2.2 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 7 | Optimization Visit 2 (Follow Up 2) | 5.2 score on a scale | Standard Deviation 2.2 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 7 | Optimization Visit 3 (Follow Up 3) | 4.2 score on a scale | Standard Deviation 2 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 7 | Start of Titration Phase (Follow Up 4) | 4.0 score on a scale | Standard Deviation 2 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 7 | 2-Week Titration Phase (Follow Up 5) | 4.6 score on a scale | Standard Deviation 2.3 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 7 | 4-Week Titration Phase (Follow Up 6) | 3.6 score on a scale | Standard Deviation 2.3 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 7 | End of Titration Phase (Follow Up 7) | 3.2 score on a scale | Standard Deviation 1.7 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 7 | 1-Month Post Titration Phase (Follow Up 8) | 3.3 score on a scale | Standard Deviation 2.1 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 7 | 2-Months Post Titration Phase (Follow Up 9) | 4.3 score on a scale | Standard Deviation 3.1 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 7 | 3-Months Post Titration Phase (Final Study Visit) | 3.0 score on a scale | Standard Deviation 3.1 |
Primary
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.
Time frame: Up to 0.5 months
Population: Number analyzed refers to patients with measure available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 8 | Enrollment | 3 score on a scale | Standard Deviation 1.83 |
| Cohort 1: Low Energy - Continuous Initial | Numeric Pain Rating Scale (NPRS) - Cohort 8 | Final Study Visit | 3.25 score on a scale | Standard Deviation 2.22 |