Trial Outcomes & Findings for DTM (TM) Spinal Cord Stimulation (SCS) Study (NCT NCT04601454)
NCT ID: NCT04601454
Last Updated: 2023-02-24
Results Overview
To characterize changes in overall (back and leg) pain intensity. Pain will be assessed using a VAS (0-10 cm) with 0 cm meaning "no pain" and 10 cm meaning "worst pain imaginable". Overall pain is defined as a combination of back and leg pain, but not pain from other body parts. Subjects will be asked to report their average pain intensity that is related to their SCS device treatment "in the last 24 hours" by marking a line perpendicular to the VAS line at the point that represents their pain intensity.
COMPLETED
NA
57 participants
Baseline to 3 Months
2023-02-24
Participant Flow
Participant milestones
| Measure |
Spinal Cord Stimulation
Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Spinal Cord Stimulation System: Implanted rechargeable neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.
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Overall Study
STARTED
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57
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Overall Study
Completed Per Protocol at the 12 Month Visit
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27
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Overall Study
COMPLETED
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32
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Overall Study
NOT COMPLETED
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25
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DTM (TM) Spinal Cord Stimulation (SCS) Study
Baseline characteristics by cohort
| Measure |
Spinal Cord Stimulation
n=57 Participants
Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Spinal Cord Stimulation System: Implanted rechargeable neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.
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Age, Continuous
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63.2 years
STANDARD_DEVIATION 11.93 • n=99 Participants
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Sex: Female, Male
Female
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33 Participants
n=99 Participants
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Sex: Female, Male
Male
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24 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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53 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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3 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=99 Participants
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Race (NIH/OMB)
White
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54 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=99 Participants
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Region of Enrollment
United States
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57 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Baseline to 3 MonthsTo characterize changes in overall (back and leg) pain intensity. Pain will be assessed using a VAS (0-10 cm) with 0 cm meaning "no pain" and 10 cm meaning "worst pain imaginable". Overall pain is defined as a combination of back and leg pain, but not pain from other body parts. Subjects will be asked to report their average pain intensity that is related to their SCS device treatment "in the last 24 hours" by marking a line perpendicular to the VAS line at the point that represents their pain intensity.
Outcome measures
| Measure |
Spinal Cord Stimulation
n=32 Participants
Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Spinal Cord Stimulation System: Implanted rechargeable neurostimulation system (neurostimulator and leads) with on-label stimulation parameters per protocol. Outcome measures were provided at baseline and 3 month visits and compared. Difference in VAS was calculated such that a negative value indicates a reduction in pain related to the VAS from baseline.
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Visual Analog Scale (VAS)
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-3.9 Centimeter
Standard Deviation 2.45
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SECONDARY outcome
Timeframe: 12 MonthPopulation: Frequencies reported represent the range of the sum of active programs across all subjects. Patients analyzed included those who completed the study per protocol at the 12 month visit.
To characterize programming parameters associated with energy use. Subject's programmed frequency settings will be summarized using the minimum and maximum frequency across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
Outcome measures
| Measure |
Spinal Cord Stimulation
n=27 Participants
Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Spinal Cord Stimulation System: Implanted rechargeable neurostimulation system (neurostimulator and leads) with on-label stimulation parameters per protocol. Outcome measures were provided at baseline and 3 month visits and compared. Difference in VAS was calculated such that a negative value indicates a reduction in pain related to the VAS from baseline.
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Programming Parameters: Frequency in Hertz (Hz)
Range Minimum
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250.0 Hertz (Hz)
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Programming Parameters: Frequency in Hertz (Hz)
Range Maximum
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300.0 Hertz (Hz)
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SECONDARY outcome
Timeframe: 12 MonthPopulation: Pulse Width in microseconds (µs) reported represent the range of active programs across all subjects. Patients analyzed included those who completed the study per protocol at the 12 month visit.
To characterize programming parameters associated with energy use. Subject's programmed Pulse Width settings will be summarized using the minimum and maximum Pulse Width across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
Outcome measures
| Measure |
Spinal Cord Stimulation
n=27 Participants
Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Spinal Cord Stimulation System: Implanted rechargeable neurostimulation system (neurostimulator and leads) with on-label stimulation parameters per protocol. Outcome measures were provided at baseline and 3 month visits and compared. Difference in VAS was calculated such that a negative value indicates a reduction in pain related to the VAS from baseline.
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Programming Parameters: Pulse Width in Microseconds (µs)
Range Minimum
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200.0 microseconds (µs)
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Programming Parameters: Pulse Width in Microseconds (µs)
Range Maximum
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200.0 microseconds (µs)
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SECONDARY outcome
Timeframe: 12 MonthPopulation: Amplitude (intensity) in milliamp (mA) reported represent the range of active programs across all subjects. Patients analyzed included those who completed the study per protocol at the 12 month visit.
To characterize programming parameters associated with energy use. Subject's programmed Amplitude settings will be summarized using the minimum and maximum Amplitude across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
Outcome measures
| Measure |
Spinal Cord Stimulation
n=27 Participants
Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Spinal Cord Stimulation System: Implanted rechargeable neurostimulation system (neurostimulator and leads) with on-label stimulation parameters per protocol. Outcome measures were provided at baseline and 3 month visits and compared. Difference in VAS was calculated such that a negative value indicates a reduction in pain related to the VAS from baseline.
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|---|---|
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Programming Parameters: Amplitude (Intensity) in Milliamp (mA)
Range Minimum
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0.70 milliamp (mA)
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Programming Parameters: Amplitude (Intensity) in Milliamp (mA)
Range Maximum
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7.3 milliamp (mA)
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SECONDARY outcome
Timeframe: 12 MonthPopulation: Impedance (ohms) reported represent the range of active programs across all subjects. Patients analyzed included those who completed the study per protocol at the 12 month visit.
To characterize programming parameters associated with energy use. Subject's programmed Impedance settings will be summarized using the minimum and maximum Impedance across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
Outcome measures
| Measure |
Spinal Cord Stimulation
n=27 Participants
Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Spinal Cord Stimulation System: Implanted rechargeable neurostimulation system (neurostimulator and leads) with on-label stimulation parameters per protocol. Outcome measures were provided at baseline and 3 month visits and compared. Difference in VAS was calculated such that a negative value indicates a reduction in pain related to the VAS from baseline.
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Programming Parameters: Impedance Range in Ohms
Range Minimum
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670.0 ohms
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Programming Parameters: Impedance Range in Ohms
Range Maximum
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2,020.0 ohms
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Adverse Events
Spinal Cord Stimulation
Serious adverse events
| Measure |
Spinal Cord Stimulation
n=57 participants at risk
Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Spinal Cord Stimulation System: Implanted rechargeable neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.
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|---|---|
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Infections and infestations
Implant site infection
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1.8%
1/57 • Adverse events will be collected throughout the study duration, starting at the time of signing the informed consent through the subjects12 month visit, or study completion.
All device-related, procedure-related, and therapy-related adverse events will be considered reportable for this study. Adverse events will be collected on an Adverse Event Case Report Form.
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Other adverse events
| Measure |
Spinal Cord Stimulation
n=57 participants at risk
Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Spinal Cord Stimulation System: Implanted rechargeable neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.
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General disorders
Medical device site oedema
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1.8%
1/57 • Adverse events will be collected throughout the study duration, starting at the time of signing the informed consent through the subjects12 month visit, or study completion.
All device-related, procedure-related, and therapy-related adverse events will be considered reportable for this study. Adverse events will be collected on an Adverse Event Case Report Form.
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General disorders
Medical device site pain
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3.5%
2/57 • Adverse events will be collected throughout the study duration, starting at the time of signing the informed consent through the subjects12 month visit, or study completion.
All device-related, procedure-related, and therapy-related adverse events will be considered reportable for this study. Adverse events will be collected on an Adverse Event Case Report Form.
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Injury, poisoning and procedural complications
Incision site complication
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1.8%
1/57 • Adverse events will be collected throughout the study duration, starting at the time of signing the informed consent through the subjects12 month visit, or study completion.
All device-related, procedure-related, and therapy-related adverse events will be considered reportable for this study. Adverse events will be collected on an Adverse Event Case Report Form.
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Injury, poisoning and procedural complications
Incision site swelling
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1.8%
1/57 • Adverse events will be collected throughout the study duration, starting at the time of signing the informed consent through the subjects12 month visit, or study completion.
All device-related, procedure-related, and therapy-related adverse events will be considered reportable for this study. Adverse events will be collected on an Adverse Event Case Report Form.
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Musculoskeletal and connective tissue disorders
Groin pain
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1.8%
1/57 • Adverse events will be collected throughout the study duration, starting at the time of signing the informed consent through the subjects12 month visit, or study completion.
All device-related, procedure-related, and therapy-related adverse events will be considered reportable for this study. Adverse events will be collected on an Adverse Event Case Report Form.
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Product Issues
Lead dislodgement
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3.5%
2/57 • Adverse events will be collected throughout the study duration, starting at the time of signing the informed consent through the subjects12 month visit, or study completion.
All device-related, procedure-related, and therapy-related adverse events will be considered reportable for this study. Adverse events will be collected on an Adverse Event Case Report Form.
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Musculoskeletal and connective tissue disorders
Back Pain
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3.5%
2/57 • Adverse events will be collected throughout the study duration, starting at the time of signing the informed consent through the subjects12 month visit, or study completion.
All device-related, procedure-related, and therapy-related adverse events will be considered reportable for this study. Adverse events will be collected on an Adverse Event Case Report Form.
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Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
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1.8%
1/57 • Adverse events will be collected throughout the study duration, starting at the time of signing the informed consent through the subjects12 month visit, or study completion.
All device-related, procedure-related, and therapy-related adverse events will be considered reportable for this study. Adverse events will be collected on an Adverse Event Case Report Form.
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Nervous system disorders
Paresthesia
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1.8%
1/57 • Adverse events will be collected throughout the study duration, starting at the time of signing the informed consent through the subjects12 month visit, or study completion.
All device-related, procedure-related, and therapy-related adverse events will be considered reportable for this study. Adverse events will be collected on an Adverse Event Case Report Form.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place