Trial Outcomes & Findings for Burst Optimized Stimulation Study (NCT NCT02896361)
NCT ID: NCT02896361
Last Updated: 2019-05-30
Results Overview
Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
assessed every 2 weeks after each intervention, for a total of 6 weeks
Results posted on
2019-05-30
Participant Flow
29 patients were screened for elegibility between july 2016 and may 2017 Dusseldorf (GER) and Wilrijk (BEL)
27 of the 29 participants received the study intervention. Of those did not receive study intervention, 1 did not meet inclusion/exlusion criteria and 1 was withdrawn for non compliance.
Participant milestones
| Measure |
Stimulation Order 1
Stimulations delivered in following order:
1. Standard burst for 2 weeks
2. Burst Microdosing 1 for 2 weeks
3. Burst Microdosing 2 for 2 weeks
Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones
|
Stimulation Order 2
Stimulations delivered in following order:
1. Burst Microdosing 1 for 2 weeks
2. Burst Microdosing 2 for 2 weeks
3. Standard burst for 2 weeks
Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones
|
Stimulation Order 3
Stimulations delivered in following order:
1. Burst Microdosing 2 for 2 weeks
2. Standard burst for 2 weeks
3. Burst Microdosing 1 for 2 weeks
Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones
|
|---|---|---|---|
|
First Intervention (2 Weeks)
STARTED
|
9
|
10
|
8
|
|
First Intervention (2 Weeks)
COMPLETED
|
9
|
10
|
8
|
|
First Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Intervention (2 Weeks)
STARTED
|
9
|
10
|
8
|
|
Second Intervention (2 Weeks)
COMPLETED
|
9
|
10
|
8
|
|
Second Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Intervention (2 Weeks)
STARTED
|
9
|
10
|
8
|
|
Third Intervention (2 Weeks)
COMPLETED
|
8
|
9
|
8
|
|
Third Intervention (2 Weeks)
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Stimulation Order 1
Stimulations delivered in following order:
1. Standard burst for 2 weeks
2. Burst Microdosing 1 for 2 weeks
3. Burst Microdosing 2 for 2 weeks
Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones
|
Stimulation Order 2
Stimulations delivered in following order:
1. Burst Microdosing 1 for 2 weeks
2. Burst Microdosing 2 for 2 weeks
3. Standard burst for 2 weeks
Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones
|
Stimulation Order 3
Stimulations delivered in following order:
1. Burst Microdosing 2 for 2 weeks
2. Standard burst for 2 weeks
3. Burst Microdosing 1 for 2 weeks
Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol: Stimulation parameters are reprogrammed from original values to study defined ones
|
|---|---|---|---|
|
Third Intervention (2 Weeks)
Protocol Violation
|
1
|
0
|
0
|
|
Third Intervention (2 Weeks)
emergenge of several new painful regions
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Subjects
n=29 Participants
Baseline characteristics for all subjects
|
|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 12 • n=29 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=29 Participants
|
|
Region of Enrollment
Germany
|
17 participants
n=29 Participants
|
|
Region of Enrollment
Belgium
|
12 participants
n=29 Participants
|
PRIMARY outcome
Timeframe: assessed every 2 weeks after each intervention, for a total of 6 weeksStandard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain
Outcome measures
| Measure |
Microdosing A(5:5)
n=25 Participants
Microdosing A: five seconds of Burst SCS alternating with five seconds of no stimulation
|
Microdosing B: 5:10
n=25 Participants
Microdosing B: five seconds of Burst SCS alternating with ten seconds of no stimulation
|
Continuous
n=25 Participants
Continuously delivered burst SCS
|
|---|---|---|---|
|
Visual Analog Scale (VAS) for Pain
|
46.88 units on a scale
Standard Deviation 23.5
|
48.60 units on a scale
Standard Deviation 21.48
|
46.76 units on a scale
Standard Deviation 21.88
|
SECONDARY outcome
Timeframe: assessed every 2 weeks after each intervention, for a total of 6 weeksEuropean Quality of life questionnaire 5 dimensions. Range goes from 0 to 1. 0 represents low quality of life, 1 represents high quality of life
Outcome measures
| Measure |
Microdosing A(5:5)
n=25 Participants
Microdosing A: five seconds of Burst SCS alternating with five seconds of no stimulation
|
Microdosing B: 5:10
n=25 Participants
Microdosing B: five seconds of Burst SCS alternating with ten seconds of no stimulation
|
Continuous
n=25 Participants
Continuously delivered burst SCS
|
|---|---|---|---|
|
EQ-5D
|
0.59 score on a scale
Standard Deviation 0.2
|
0.62 score on a scale
Standard Deviation 0.19
|
0.59 score on a scale
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: assessed 6 weeks after baseline at the last follow up visitquestionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were * first intervention * second intervention * third intervention * no preference
Outcome measures
| Measure |
Microdosing A(5:5)
n=8 Participants
Microdosing A: five seconds of Burst SCS alternating with five seconds of no stimulation
|
Microdosing B: 5:10
n=9 Participants
Microdosing B: five seconds of Burst SCS alternating with ten seconds of no stimulation
|
Continuous
n=8 Participants
Continuously delivered burst SCS
|
|---|---|---|---|
|
Subject Preference
first intervention
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Subject Preference
second intervention
|
1 Participants
|
5 Participants
|
3 Participants
|
|
Subject Preference
third intervention
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Subject Preference
no preference
|
3 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: assessed every 2 weeks after each intervention, for a total of 6 weeksquestionnaire on satisfaction with current therapy
Outcome measures
| Measure |
Microdosing A(5:5)
n=25 Participants
Microdosing A: five seconds of Burst SCS alternating with five seconds of no stimulation
|
Microdosing B: 5:10
n=25 Participants
Microdosing B: five seconds of Burst SCS alternating with ten seconds of no stimulation
|
Continuous
n=25 Participants
Continuously delivered burst SCS
|
|---|---|---|---|
|
Subject Satisfaction
Dissatisfied
|
3 Participants
|
5 Participants
|
7 Participants
|
|
Subject Satisfaction
Neither satisfied or dissatisfied
|
12 Participants
|
8 Participants
|
8 Participants
|
|
Subject Satisfaction
satisfied
|
9 Participants
|
10 Participants
|
7 Participants
|
|
Subject Satisfaction
very dissatisfied
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Subject Satisfaction
very satisfied
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: assessed over 6 weeks of study participationOutcome measures
| Measure |
Microdosing A(5:5)
n=27 Participants
Microdosing A: five seconds of Burst SCS alternating with five seconds of no stimulation
|
Microdosing B: 5:10
Microdosing B: five seconds of Burst SCS alternating with ten seconds of no stimulation
|
Continuous
Continuously delivered burst SCS
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events
|
3.7 percentage of patients with AE
|
—
|
—
|
Adverse Events
Standard Burst
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Burst Microdosing 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Burst Microdosing 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Burst
n=26 participants at risk
reporting "per intervention" adverse events experienced while standard continuous burst was delivered
|
Burst Microdosing 1
n=27 participants at risk
reporting "per intervention" adverse events experienced while burst microdosing 1 was delivered
|
Burst Microdosing 2
n=26 participants at risk
reporting "per intervention" adverse events experienced while burst microdosing 2 was delivered
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bilateral ISG syndrome
|
0.00%
0/26 • 6 weeks
|
0.00%
0/27 • 6 weeks
|
3.8%
1/26 • Number of events 1 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place