Trial Outcomes & Findings for Objective Assessment of Activity and Sleep Quality In Burst Spinal Cord Stimulation (NCT NCT02950831)

NCT ID: NCT02950831

Last Updated: 2019-08-29

Results Overview

Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: between baseline and the end of spinal cord stimulation trial period (average of 1 month)
• Results posted on: 2019-08-29

Participant Flow

Participant milestones

Measure	Activity and Sleep Quality Recording Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Overall Study STARTED	27
Overall Study Complete Trial	26
Overall Study Permanent Implant	20
Overall Study 4 Week Follow up	20
Overall Study 8 Weeks Follow up	19
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Activity and Sleep Quality Recording Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	3
Overall Study stimulation trail failure	5

Baseline Characteristics

Objective Assessment of Activity and Sleep Quality In Burst Spinal Cord Stimulation

Baseline characteristics by cohort

Measure	Activity and Sleep Quality Recording n=27 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	51.8 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	27 Participants n=5 Participants
Region of Enrollment Netherlands	22 participants n=5 Participants
Region of Enrollment Belgium	5 participants n=5 Participants

PRIMARY outcome

Timeframe: between baseline and the end of spinal cord stimulation trial period (average of 1 month)

Population: Average change in MVPA (h/day) from baseline value is reported. Activity recording files were not available for 2 patients.

Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day.

Outcome measures

Measure	Activity and Sleep Quality Recording n=24 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Activity Levels	-0.17 change in MVPA h/day from baseline value Standard Deviation 0.22

PRIMARY outcome

Timeframe: between baseline and the end of spinal cord stimulation trial period (average of 1 month)

Population: Change in average sleep duration from baseline value is reported. Activity recording files were not available for 2 patients.

Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.

Outcome measures

Measure	Activity and Sleep Quality Recording n=24 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Sleep Quality	-0.05 Change h/day from baseline value Standard Deviation 1.05

SECONDARY outcome

Timeframe: between baseline and the end of spinal cord stimulation trial period (average of 1 month)

Population: Percentage change in average VAS value from baseline is reported (pain relief) Data was not available for 1 subject

Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)

Outcome measures

Measure	Activity and Sleep Quality Recording n=25 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Visual Analog Scale (VAS) for Pain	-57.73 Percentage reduction from baseline score Standard Error 31.4

SECONDARY outcome

Timeframe: between baseline and 1 month post permanent spinal cord stimulator activation followup

Population: Percentage reduction in average VAS value from baseline is reported (pain relief)

Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)

Outcome measures

Measure	Activity and Sleep Quality Recording n=20 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Visual Analog Scale (VAS) for Pain	-49.04 Percentage change from baseline score Standard Error 47.49

SECONDARY outcome

Timeframe: between baseline and 2 month post permanent spinal cord stimulator activation followup

Population: Percentage change in average VAS value from baseline is reported (pain relief)

Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)

Outcome measures

Measure	Activity and Sleep Quality Recording n=19 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Visual Analog Scale (VAS) for Pain	-53.55 Percentage reduction from baseline score Standard Deviation 43.81

SECONDARY outcome

Timeframe: between baseline and 3 month post permanent spinal cord stimulator activation followup

Population: Percentage change in average VAS value from baseline is reported (pain relief)

Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)

Outcome measures

Measure	Activity and Sleep Quality Recording n=18 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Visual Analog Scale (VAS) for Pain	52.04 Percentage change from baseline score Standard Deviation 44.95

SECONDARY outcome

Timeframe: between baseline and the end of spinal cord stimulation trial period (average of 1 month)

Population: Change in average EQ-5D scores from baseline is reported

Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life.

Outcome measures

Measure	Activity and Sleep Quality Recording n=26 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in European Quality of Life 5 Dimensions (EQ-5D)	0.23 change in score on a scale Standard Deviation 0.12

SECONDARY outcome

Timeframe: between baseline and 1 month post permanent spinal cord stimulator activation followup

Population: Change in average EQ-5D scores from baseline is reported

Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life

Outcome measures

Measure	Activity and Sleep Quality Recording n=20 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in European Quality of Life 5 Dimensions (EQ-5D)	0.19 change in score on a scale Standard Deviation 0.17

SECONDARY outcome

Timeframe: between baseline and 2 month post permanent spinal cord stimulator activation followup

Population: Change in average EQ-5D scores from baseline is reported

Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life

Outcome measures

Measure	Activity and Sleep Quality Recording n=19 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in European Quality of Life 5 Dimensions (EQ-5D)	0.23 change in score on a scale Standard Deviation 0.14

SECONDARY outcome

Timeframe: between baseline and 3 month post permanent spinal cord stimulator activation followup

Population: Change in average EQ-5D scores from baseline is reported

Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life

Outcome measures

Measure	Activity and Sleep Quality Recording n=18 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in European Quality of Life 5 Dimensions (EQ-5D)	0.18 change in score on a scale Standard Deviation 0.19

SECONDARY outcome

Timeframe: between baseline and the end of spinal cord stimulation trial period (average of 1 month)

Population: Percentage change in average ODI value from baseline is reported. One patient did not complete the ODI form correctly.

Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.

Outcome measures

Measure	Activity and Sleep Quality Recording n=25 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Oswestry Disability Index (ODI)	-18.6 change in score on a scale Standard Error 15.8

SECONDARY outcome

Timeframe: between baseline and 1 month post permanent spinal cord stimulator activation followup

Population: Change in average ODI value from baseline is reported.

Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.

Outcome measures

Measure	Activity and Sleep Quality Recording n=20 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Oswestry Disability Index (ODI)	-17.4 change in score on a scale Standard Deviation 14.6

SECONDARY outcome

Timeframe: between baseline and 2 month post permanent spinal cord stimulator activation followup

Population: Change in average ODI value from baseline is reported.

Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.

Outcome measures

Measure	Activity and Sleep Quality Recording n=19 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Oswestry Disability Index (ODI)	-18.8 change in score on a scale Standard Deviation 14.0

SECONDARY outcome

Timeframe: between baseline and 3 month post permanent spinal cord stimulator activation followup

Population: Change in average ODI value from baseline is reported.

Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.

Outcome measures

Measure	Activity and Sleep Quality Recording n=18 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Oswestry Disability Index (ODI)	-19.1 change in score on a scale Standard Deviation 13.6

SECONDARY outcome

Timeframe: between baseline and 1 month post permanent spinal cord stimulator activation followup

Population: Average change in MVPA (h/day) from baseline value is reported. Activity recording files were not available for 1 patient

Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day.

Average percent change in MVPA from baseline value is reported.

Outcome measures

Measure	Activity and Sleep Quality Recording n=19 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Activity Levels	-0.01 change in MVPA h/day from baseline value Standard Deviation 0.09

SECONDARY outcome

Timeframe: between baseline and 1 month post permanent spinal cord stimulator activation followup

Population: Change in average sleep duration from baseline value is reported. Activity recording files were not available for 1 patient

Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.

Outcome measures

Measure	Activity and Sleep Quality Recording n=19 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Sleep Quality	0.1 Change h/day from baseline value Standard Deviation 0.82

SECONDARY outcome

Timeframe: between baseline and 2 month post permanent spinal cord stimulator activation followup

Population: Average change in MVPA (h/day) from baseline value is reported. Activity recording files were not available for 1 patient

Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day.

Average percent change in MVPA from baseline value is reported.

Outcome measures

Measure	Activity and Sleep Quality Recording n=18 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Activity Levels	0.03 change in MVPA h/day from baseline value Standard Deviation 0.08

SECONDARY outcome

Timeframe: between baseline and 2 month post permanent spinal cord stimulator activation followup

Population: Change in average sleep duration from baseline value is reported. Activity recording files were not available for 1 patient

Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.

Outcome measures

Measure	Activity and Sleep Quality Recording n=18 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Sleep Quality	-0.06 Change h/day from baseline value Standard Deviation 0.81

SECONDARY outcome

Timeframe: between baseline and 3 month post permanent spinal cord stimulator activation followup

Population: Average change in MVPA (h/day) from baseline value is reported. Activity files were not available for 5 patients

Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day.

Average percent change in MVPA from baseline value is reported.

Outcome measures

Measure	Activity and Sleep Quality Recording n=13 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Activity Levels	0.02 change in MVPA h/day from baseline value Standard Deviation 0.08

SECONDARY outcome

Timeframe: between baseline and 3 month post permanent spinal cord stimulator activation followup

Population: Percent change in average sleep duration from baseline value is reported. Activity files were not available for 5 patients

Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.

Outcome measures

Measure	Activity and Sleep Quality Recording n=13 Participants Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Change in Sleep Quality	0 Change h/day from baseline value Standard Deviation 0.61

Adverse Events

Activity and Sleep Quality Recording

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Activity and Sleep Quality Recording n=27 participants at risk Patients will receive a wrist worn accelerometer and accelerometry will be used to monitor physical activity and sleep quality during standard BurstDR Spinal Cord Stimulation clinical treatment Accelerometry: Record of activity levels using a wrist worn accelerometer
Nervous system disorders Increased pain/inadequate pain relief that required device reprogramming	7.4% 2/27 • Number of events 4 • From baseline to 3rd month follow up for an average duration of 4.6 months (including trial and wait time between trial and permanent implant)
General disorders IPG pocket pain	3.7% 1/27 • Number of events 1 • From baseline to 3rd month follow up for an average duration of 4.6 months (including trial and wait time between trial and permanent implant)

Additional Information

Filippo Agnesi

St. Jude Medical

Phone: 14694184987

Email: filippo.agnesi@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place