Trial Outcomes & Findings for BurstDR™ micrOdosing stimuLation in De-novo Patients (NCT NCT03350256)

Results Overview

Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

baseline and 1 week after trial lead implant (trial stimulation)

Results posted on

2020-03-19

Participant Flow

Participant milestones

Participant milestones
Measure	Microdosing Group Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Overall Study STARTED	60
Overall Study Spinal Cord Stimulation Trial	50
Overall Study Permanent Implant	35
Overall Study 1 Month Follow up	30
Overall Study 3 Month Follow up	27
Overall Study 6 Month Follow up	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Microdosing Group Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Overall Study Inclusion/exclusion violation	4
Overall Study Recommended for other therapies	2
Overall Study Protocol Violation	3
Overall Study Non compliance	2
Overall Study Denial by insurance	1
Overall Study Adverse Event	2
Overall Study Trial failure	12
Overall Study Did not proceed to permanent implant	3
Overall Study Withdrawal by Subject	3
Overall Study Subject moving out of state	1
Overall Study Lost to Follow-up	1
Overall Study Lack of Efficacy	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Microdosing Group n=49 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Age, Continuous	56.8 years STANDARD_DEVIATION 3.95 • n=49 Participants
Sex: Female, Male Female	30 Participants n=49 Participants
Sex: Female, Male Male	19 Participants n=49 Participants
Region of Enrollment United States	49 participants n=49 Participants
duration of pain	9.98 years STANDARD_DEVIATION 3.31 • n=48 Participants • One subject had missing data for duration of pain

PRIMARY outcome

Timeframe: baseline and 1 week after trial lead implant (trial stimulation)

Population: Change in visual analogue scale score between baseline and spinal cord stimulation (SCS) trial missing data for 3 subjects

Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

Outcome measures

Outcome measures
Measure	Microdosing Group n=47 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation	-46.28 units on a scale Standard Deviation 23.83

PRIMARY outcome

Timeframe: Baseline and 1 month follow up visit

Population: Change in VAS score between baseline and 1 month follow up missing data for 2 subjects

Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

Outcome measures

Outcome measures
Measure	Microdosing Group n=28 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1	-41.07 units on a scale Standard Deviation 24.74

PRIMARY outcome

Timeframe: Baseline and 3 month follow up visit

Population: Change in VAS between baseline and 3 month follow up missing data for 2 subject

Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

Outcome measures

Outcome measures
Measure	Microdosing Group n=25 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2	-36.56 units on a scale Standard Deviation 29.53

PRIMARY outcome

Timeframe: Baseline and 6 month follow up visit

Population: Change in VAS score between baseline and 6 months visit

Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)

Outcome measures

Outcome measures
Measure	Microdosing Group n=24 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3	-36.62 units on a scale Standard Deviation 29.54

SECONDARY outcome

Timeframe: Baseline and 1 week after trial lead implant (trial stimulation)

Population: Change in EQ-5D score between baseline and SCS trial 1 subject had missing data

Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)

Outcome measures

Outcome measures
Measure	Microdosing Group n=49 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Quality of Life Between Baseline and Trial Stimulation	0.172 score on a scale Standard Deviation 0.1625

SECONDARY outcome

Timeframe: Baseline and 1 month follow up visit

Population: Change in EQ-5D score between baseline and 1 month follow up Two subjects had missing data

Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)

Outcome measures

Outcome measures
Measure	Microdosing Group n=28 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Quality of Life Between Baseline and Follow up 1	0.148 score on a scale Standard Deviation 0.121

SECONDARY outcome

Timeframe: Baseline and 3 month follow up visit

Population: Change in EQ-5D score between baseline and 3 month follow up One subjects had missing data

Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)

Outcome measures

Outcome measures
Measure	Microdosing Group n=26 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Quality of Life Between Baseline and Follow up 2	0.106 score on a scale Standard Error 0.209

SECONDARY outcome

Timeframe: Baseline and 6 month follow up visit

Population: Change in EQ-5D score between baseline and 6 month follow up

Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)

Outcome measures

Outcome measures
Measure	Microdosing Group n=24 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Quality of Life Between Baseline and Follow up 3	0.148 score on a scale Standard Deviation 0.136

SECONDARY outcome

Timeframe: Baseline and 1 week after trial lead implant (trial stimulation)

Population: Change in ODI score between baseline and SCS trial 3 subjects had missing data

questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

Outcome measures

Outcome measures
Measure	Microdosing Group n=47 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Disability Index Between Baseline and Trial Stimulation	-17.6 score on a scale Standard Deviation 18.15

SECONDARY outcome

Timeframe: Baseline and 1 month follow up visit

Population: Change in ODI score between baseline and 1 month follow up 2 subjects had missing data

questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

Outcome measures

Outcome measures
Measure	Microdosing Group n=28 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Disability Index Between Baseline and and Follow up 1	-12.76 score on a scale Standard Deviation 14.5

SECONDARY outcome

Timeframe: Baseline and 3 month follow up visit

Population: Change in disability score between baseline and 3 month follow up Two subjects had missing data

questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

Outcome measures

Outcome measures
Measure	Microdosing Group n=26 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Disability Index Between Baseline and and Follow up 2	-17 score on a scale Standard Deviation 19.1

SECONDARY outcome

Timeframe: Baseline and 6 month follow up visit

Population: Change in disability score between baseline and 6 month follow up

questionnaire on disability (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)

Outcome measures

Outcome measures
Measure	Microdosing Group n=24 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Disability Index Between Baseline and and Follow up 3	-15.5 score on a scale Standard Deviation 16.6

SECONDARY outcome

Timeframe: Baseline and 1 week after trial lead implant (trial stimulation)

Population: Change in PCS between baseline and SCS trial One subject had missing data

Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)

Outcome measures

Outcome measures
Measure	Microdosing Group n=49 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation	-8.98 score on a scale Standard Deviation 12.3

SECONDARY outcome

Timeframe: Baseline and 1 month follow up visit

Population: Change in PCS score between baseline and 1 month follow up 2 subjects had missing data

Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)

Outcome measures

Outcome measures
Measure	Microdosing Group n=28 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Pain Catastrophizing Scale Between Baseline and Follow up 1	-12.17 score on a scale Standard Deviation 12.83

SECONDARY outcome

Timeframe: Baseline and 3 month follow up visit

Population: Change in PCS between baseline and 3 month follow up 2 subjects had missing data

Questionnaire on pain catastrophizing (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)

Outcome measures

Outcome measures
Measure	Microdosing Group n=26 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Pain Catastrophizing Scale Between Baseline and Follow up 2	-13.32 score on a scale Standard Deviation 14.38

SECONDARY outcome

Timeframe: Baseline and 6 month follow up visit

Population: Change in PCS score between baseline and 6 month follow up 1 subject had missing data

Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)

Outcome measures

Outcome measures
Measure	Microdosing Group n=23 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Change in Pain Catastrophizing Scale Between Baseline and Follow up 3	-13.42 score on a scale Standard Deviation 12.68

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 month follow up visit

Percentage of patients using each ON/OFF ratio

Outcome measures

Outcome measures
Measure	Microdosing Group n=24 Participants Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Stimulation ON/OFF Ratio subjects using 360 seconds OFF intervals	11 Participants
Stimulation ON/OFF Ratio subjects using 240 seconds OFF intervals	3 Participants
Stimulation ON/OFF Ratio subjects using 150 seconds OFF intervals	3 Participants
Stimulation ON/OFF Ratio subjects using 120 seconds OFF intervals	3 Participants
Stimulation ON/OFF Ratio subjects using 90 seconds OFF intervals	4 Participants

Adverse Events

Microdosing Group

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Microdosing Group n=60 participants at risk Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Injury, poisoning and procedural complications Subject fractured <1 vertebrae (compression) and was hospitalized overnight	1.7% 1/60 • Number of events 1 • From enrollment to completion of the study at 6 month follow up.
General disorders Hospitalization for abdominal pain	1.7% 1/60 • Number of events 1 • From enrollment to completion of the study at 6 month follow up.

Other adverse events

Other adverse events
Measure	Microdosing Group n=60 participants at risk Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
Injury, poisoning and procedural complications Trial lead migration	5.0% 3/60 • Number of events 3 • From enrollment to completion of the study at 6 month follow up.

Additional Information

Filippo Agnesi

Abbott

Phone: +19725264860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place