Trial Outcomes & Findings for Pilot Study to Examine the Feasibility of the Dynamic Interferential Spinal Cord Stimulation System™ (DISCSS™) (NCT NCT03341000)
NCT ID: NCT03341000
Last Updated: 2024-04-08
Results Overview
Change from baseline (day 1) to visit 5 (day 10-11) in patient-reported pain intensity, measured on a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Baseline to visit 5
Results posted on
2024-04-08
Participant Flow
Participant milestones
| Measure |
DISCSS Device
This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system within the first 3-5 days of this study.
DISCSS Device: This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system within the first 3-5 days of this study.
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|---|---|
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Overall Study
STARTED
|
18
|
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Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
DISCSS Device
This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system within the first 3-5 days of this study.
DISCSS Device: This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system within the first 3-5 days of this study.
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|---|---|
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Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Pilot Study to Examine the Feasibility of the Dynamic Interferential Spinal Cord Stimulation System™ (DISCSS™)
Baseline characteristics by cohort
| Measure |
DISCSS Device
n=18 Participants
This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system.
DISCSS Device: This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system.
|
|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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13 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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5 Participants
n=99 Participants
|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 11.6 • n=99 Participants
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Sex: Female, Male
Female
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9 Participants
n=99 Participants
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Sex: Female, Male
Male
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9 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
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1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
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17 Participants
n=99 Participants
|
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Height
|
67.6 Inches
STANDARD_DEVIATION 4.7 • n=99 Participants
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PRIMARY outcome
Timeframe: Baseline to visit 5Population: Intent to treat.
Change from baseline (day 1) to visit 5 (day 10-11) in patient-reported pain intensity, measured on a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain).
Outcome measures
| Measure |
DISCSS Device
n=17 Participants
This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system.
DISCSS Device: This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system.
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|---|---|
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Change From Baseline (Day 1) to Visit 5 in Back Pain.
Lower Extremity
|
-3.9 score on a scale
Standard Deviation 2.5
|
|
Change From Baseline (Day 1) to Visit 5 in Back Pain.
Overall
|
-4.2 score on a scale
Standard Deviation 2.3
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Change From Baseline (Day 1) to Visit 5 in Back Pain.
Back
|
-4.4 score on a scale
Standard Deviation 2.3
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SECONDARY outcome
Timeframe: Visit 4 (Day 6-7), and Visit 5 (Day 10-11)Population: All enrolled subjects.
Incidence of adverse events arising from the DISCSS treatment phase
Outcome measures
| Measure |
DISCSS Device
n=18 Participants
This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system.
DISCSS Device: This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system.
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|---|---|
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Incidence of Adverse Events
Serious Adverse Event
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1 Adverse Events
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Incidence of Adverse Events
Adverse Event
|
6 Adverse Events
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SECONDARY outcome
Timeframe: Visit 5 (Day 10-11)Population: Intent to treat.
Patient-reported device efficacy and device stimulation sensation as captured on a study-specific, subject satisfaction Questionnaire.
Outcome measures
| Measure |
DISCSS Device
n=17 Participants
This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system.
DISCSS Device: This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system.
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|---|---|
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Patient Satisfaction
Very Satisfied
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9 Participants
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Patient Satisfaction
Satisfied
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4 Participants
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Patient Satisfaction
Somewhat Satisfied
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3 Participants
|
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Patient Satisfaction
Dissatisfied
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1 Participants
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Adverse Events
DISCSS Device
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
SCS System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DISCSS Device
n=18 participants at risk
3-5 days of DISCSS following the completion of a 3-5 day trial with a commercially available SCS system.
|
SCS System
n=18 participants at risk
3-5 day trial with a commercially available SCS system
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|---|---|---|
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Product Issues
Percutaneous Trial Lead Fracture
|
5.6%
1/18 • Number of events 1 • Visit 1 (Day 1), Visit 2 (Day 0-3) and 3 (Day 4 - 5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
|
0.00%
0/18 • Visit 1 (Day 1), Visit 2 (Day 0-3) and 3 (Day 4 - 5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
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Other adverse events
| Measure |
DISCSS Device
n=18 participants at risk
3-5 days of DISCSS following the completion of a 3-5 day trial with a commercially available SCS system.
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SCS System
n=18 participants at risk
3-5 day trial with a commercially available SCS system
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|---|---|---|
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Musculoskeletal and connective tissue disorders
Increased Pain
|
5.6%
1/18 • Number of events 1 • Visit 1 (Day 1), Visit 2 (Day 0-3) and 3 (Day 4 - 5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
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0.00%
0/18 • Visit 1 (Day 1), Visit 2 (Day 0-3) and 3 (Day 4 - 5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
|
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Musculoskeletal and connective tissue disorders
Burning/Shocking
|
5.6%
1/18 • Number of events 1 • Visit 1 (Day 1), Visit 2 (Day 0-3) and 3 (Day 4 - 5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
|
0.00%
0/18 • Visit 1 (Day 1), Visit 2 (Day 0-3) and 3 (Day 4 - 5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
|
|
Product Issues
Lead Migration
|
11.1%
2/18 • Number of events 2 • Visit 1 (Day 1), Visit 2 (Day 0-3) and 3 (Day 4 - 5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
|
0.00%
0/18 • Visit 1 (Day 1), Visit 2 (Day 0-3) and 3 (Day 4 - 5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
|
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Musculoskeletal and connective tissue disorders
Painful Stimulation
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5.6%
1/18 • Number of events 1 • Visit 1 (Day 1), Visit 2 (Day 0-3) and 3 (Day 4 - 5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
|
0.00%
0/18 • Visit 1 (Day 1), Visit 2 (Day 0-3) and 3 (Day 4 - 5), Visit 4 (Day 6-7), and Visit 5 (Day 10-11)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place