BOSS: Burst Optimized Stimulation Study

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02896361
• Collaborator: Medizinische Einrichtungen der Universität Düsseldorf (Other), Klinikum Duisburg GmbH (Other), NKO Sint-Augustinus Antwerpen (Other)
• Enrollment: 29
• Locations: 3
• Arms: 3
• Duration (Months): 13
• Patients Per Site: 9.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Device: Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol	N/A

Detailed Description

This is a prospective, multicenter, randomized, double-blinded crossover study designed to compare conventional burst stimulation parameters to two different burst microdosing paradigms.

Subjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3 stimulation paradigms in different order.

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Burst Optimized Stimulation Study
• Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stimulation order 1 Stimulations delivered in following order: Standard burst Burst Microdosing 1 Burst Microdosing 2	Device: 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
Experimental: Stimulation order 2 Stimulations delivered in following order: Burst Microdosing 1 Burst Microdosing 2 Standard burst	Device: 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
Experimental: Stimulation order 3 Stimulations delivered in following order: Burst Microdosing 2 Standard burst Burst Microdosing 1	Device: 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

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scale (VAS) for Pain [assessed every 2 weeks after each intervention, for a total of 6 weeks]

   Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain

Secondary Outcome Measures

1. EQ-5D [assessed every 2 weeks after each intervention, for a total of 6 weeks]

   European Quality of life questionnaire 5 dimensions. Range goes from 0 to 1. 0 represents low quality of life, 1 represents high quality of life

2. Subject Preference [assessed 6 weeks after baseline at the last follow up visit]

   questionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were first intervention second intervention third intervention no preference

3. Subject Satisfaction [assessed every 2 weeks after each intervention, for a total of 6 weeks]

   questionnaire on satisfaction with current therapy

4. Percentage of Participants With Adverse Events [assessed over 6 weeks of study participation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject has been implanted with a commercially available SJM spinal cord stimulator for controlling chronic intractable pain associated with back and/or leg pain;

• Subject has been exclusively using burst stimulation for at least three months;

• Subject is 18 years of age or older;

• Subject's pain-related medication regimen was stable in the 4 weeks prior to the screening evaluation;

• Subject agrees not to add or increase pain-related medication from enrollment through the study duration;

• Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;

Exclusion Criteria:

• Subject is currently participating in a clinical investigation study that includes an active treatment arm;

• Subject is currently receiving, applying or considering seeking workers compensation, or is involved in disability litigation;

• Subject has a non SJM neuromodulation device

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NKO Sint-Augustinus	Antwerpen		Belgium	2610
2	Klinikum Duisburg GmbH	Duisburg	North Rhine-Westphalia	Germany	47055
3	Medizinische Einrichtungen der Universität Düsseldorf	Düsseldorf	North Rhine-Westphalia	Germany	40225

Sponsors and Collaborators

• Abbott Medical Devices
• Medizinische Einrichtungen der Universität Düsseldorf
• Klinikum Duisburg GmbH
• NKO Sint-Augustinus Antwerpen

Investigators

• Study Director: Lalit Venkatesan, Ph.D., Abbott Medical Devices

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 2, 2016

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT02896361
• Other Study ID Numbers: SJM-CIP-10125
• First Posted: Sep 12, 2016
• Last Update Posted: May 30, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Chronic Pain

Study Results

Participant Flow

Recruitment Details	29 patients were screened for elegibility between july 2016 and may 2017 Dusseldorf (GER) and Wilrijk (BEL)
Pre-assignment Detail	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.

Arm/Group Title	Stimulation Order 1	Stimulation Order 2	Stimulation Order 3
Arm/Group Description	Stimulations delivered in following order: Standard burst for 2 weeks Burst Microdosing 1 for 2 weeks 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	Stimulations delivered in following order: Burst Microdosing 1 for 2 weeks Burst Microdosing 2 for 2 weeks 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	Stimulations delivered in following order: Burst Microdosing 2 for 2 weeks Standard burst for 2 weeks 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
Period Title: First Intervention (2 Weeks)
STARTED	9	10	8
COMPLETED	9	10	8
NOT COMPLETED	0	0	0
Period Title: First Intervention (2 Weeks)
STARTED	9	10	8
COMPLETED	9	10	8
NOT COMPLETED	0	0	0
Period Title: First Intervention (2 Weeks)
STARTED	9	10	8
COMPLETED	8	9	8
NOT COMPLETED	1	1	0

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group Description	Baseline characteristics for all subjects
Overall Participants	29
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.9 (12)
Sex: Female, Male (Count of Participants)
Female	18 62.1%
Male	11 37.9%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Germany	17 58.6%
Belgium	12 41.4%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Scale (VAS) for Pain
Description	Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain
Time Frame	assessed every 2 weeks after each intervention, for a total of 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Microdosing A(5:5)	Microdosing B: 5:10	Continuous
Arm/Group Description	Microdosing A: five seconds of Burst SCS alternating with five seconds of no stimulation	Microdosing B: five seconds of Burst SCS alternating with ten seconds of no stimulation	Continuously delivered burst SCS
Measure Participants	25	25	25
Mean (Standard Deviation) [units on a scale]	46.88 (23.5)	48.60 (21.48)	46.76 (21.88)

2. Secondary Outcome

Title	EQ-5D
Description	European Quality of life questionnaire 5 dimensions. Range goes from 0 to 1. 0 represents low quality of life, 1 represents high quality of life
Time Frame	assessed every 2 weeks after each intervention, for a total of 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Microdosing A(5:5)	Microdosing B: 5:10	Continuous
Arm/Group Description	Microdosing A: five seconds of Burst SCS alternating with five seconds of no stimulation	Microdosing B: five seconds of Burst SCS alternating with ten seconds of no stimulation	Continuously delivered burst SCS
Measure Participants	25	25	25
Mean (Standard Deviation) [score on a scale]	0.59 (0.2)	0.62 (0.19)	0.59 (0.21)

3. Secondary Outcome

Title	Subject Preference
Description	questionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were first intervention second intervention third intervention no preference
Time Frame	assessed 6 weeks after baseline at the last follow up visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stimulation Order 1	Stimulation Order 2	Stimulation Order 3
Arm/Group Description	Stimulations delivered in following order: Standard burst for 2 weeks Burst Microdosing 1 for 2 weeks Burst Microdosing 2 for 2 weeks	Stimulations delivered in following order: Burst Microdosing 1 for 2 weeks Burst Microdosing 2 for 2 weeks Standard burst for 2 weeks	timulations delivered in following order: Burst Microdosing 2 for 2 weeks Standard burst for 2 weeks Burst Microdosing 1 for 2 weeks
Measure Participants	8	9	8
first intervention	2 6.9%	1 NaN	3 NaN
second intervention	1 3.4%	5 NaN	3 NaN
third intervention	2 6.9%	2 NaN	1 NaN
no preference	3 10.3%	1 NaN	1 NaN

4. Secondary Outcome

Title	Subject Satisfaction
Description	questionnaire on satisfaction with current therapy
Time Frame	assessed every 2 weeks after each intervention, for a total of 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Microdosing A(5:5)	Microdosing B: 5:10	Continuous
Arm/Group Description	Microdosing A: five seconds of Burst SCS alternating with five seconds of no stimulation	Microdosing B: five seconds of Burst SCS alternating with ten seconds of no stimulation	Continuously delivered burst SCS
Measure Participants	25	25	25
Dissatisfied	3 10.3%	5 NaN	7 NaN
Neither satisfied or dissatisfied	12 41.4%	8 NaN	8 NaN
satisfied	9 31%	10 NaN	7 NaN
very dissatisfied	1 3.4%	1 NaN	2 NaN
very satisfied	0 0%	1 NaN	1 NaN

5. Secondary Outcome

Title	Percentage of Participants With Adverse Events
Time Frame	assessed over 6 weeks of study participation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Subjects
Arm/Group Description	Baseline characteristics for all subjects
Measure Participants	27
Number [percentage of patients with AE]	3.7

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Standard Burst		Burst Microdosing 1		Burst Microdosing 2
Arm/Group Description	reporting "per intervention" adverse events experienced while standard continuous burst was delivered		reporting "per intervention" adverse events experienced while burst microdosing 1 was delivered		reporting "per intervention" adverse events experienced while burst microdosing 2 was delivered
All Cause Mortality
	Standard Burst		Burst Microdosing 1		Burst Microdosing 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/27 (0%)		0/26 (0%)
Serious Adverse Events
	Standard Burst		Burst Microdosing 1		Burst Microdosing 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/27 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Standard Burst		Burst Microdosing 1		Burst Microdosing 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/27 (0%)		1/26 (3.8%)
Musculoskeletal and connective tissue disorders
Bilateral ISG syndrome	0/26 (0%)	0	0/27 (0%)	0	1/26 (3.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.