Trial Outcomes & Findings for SUNBURST (Success Using Neuromodulation With BURST) Study (NCT NCT02011893)

NCT ID: NCT02011893

Last Updated: 2019-01-30

Results Overview

Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, from 0 mm to 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.

Recruitment status

COMPLETED

Study phase

Target enrollment

173 participants

Primary outcome timeframe

Over 7 days after 3 months of treatment of burst or tonic stimulation

Results posted on

2019-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Enrolled All subjects enrolled through device activation/randomization	Arm 1 Tonic stimulation first, then Burst	Arm 2 Burst stimulation first, then Tonic
Enrollment to Randomization STARTED	173	0	0
Enrollment to Randomization Baseline	141	0	0
Enrollment to Randomization Trial Stimulation Implant	121	0	0
Enrollment to Randomization Permanent Stimulation Implant	101	0	0
Enrollment to Randomization Randomization	100	0	0
Enrollment to Randomization COMPLETED	100	0	0
Enrollment to Randomization NOT COMPLETED	73	0	0
Period 1 (Randomization to 12 Weeks) STARTED	0	45	55
Period 1 (Randomization to 12 Weeks) 6 Week Follow-up	0	45	52
Period 1 (Randomization to 12 Weeks) 12 Week Follow-up	0	45	52
Period 1 (Randomization to 12 Weeks) COMPLETED	0	45	52
Period 1 (Randomization to 12 Weeks) NOT COMPLETED	0	0	3
Period 2 (12 Weeks to 24 Weeks) STARTED	0	45	52
Period 2 (12 Weeks to 24 Weeks) 18 Week Follow-up	0	44	51
Period 2 (12 Weeks to 24 Weeks) 24 Week Follow-up	0	45	51
Period 2 (12 Weeks to 24 Weeks) COMPLETED	0	45	51
Period 2 (12 Weeks to 24 Weeks) NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Enrolled All subjects enrolled through device activation/randomization	Arm 2 Burst stimulation first, then Tonic
Enrollment to Randomization Adverse Event	2	0
Enrollment to Randomization Physician Decision	10	0
Enrollment to Randomization Withdrawal by Subject	21	0
Enrollment to Randomization Screening Failure	29	0
Enrollment to Randomization Temporary Trial Stimulation Failure	9	0
Enrollment to Randomization Insurance/Financial Reasons	2	0
Period 1 (Randomization to 12 Weeks) Physician Decision	0	1
Period 1 (Randomization to 12 Weeks) Withdrawal by Subject	0	2
Period 2 (12 Weeks to 24 Weeks) Physician Decision	0	1

Baseline Characteristics

SUNBURST (Success Using Neuromodulation With BURST) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=141 Participants All subjects who were enrolled in the SUNBURST clinical study
Age, Continuous	59.1 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants

PRIMARY outcome

Timeframe: Over 7 days after 3 months of treatment of burst or tonic stimulation

Population: All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.

Outcome measures

Outcome measures
Measure	Burst Stimulation n=100 Participants Burst Stimulation using the Prodigy system Burst Stimulation: Prodigy Neurostimulation System with associated components	Tonic Stimulation n=100 Participants Tonic Stimulation using the Prodigy system Tonic Stimulation: Prodigy Neurostimulation System with associated components
Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain	43.5 mm Standard Deviation 25.6	48.7 mm Standard Deviation 23.9

SECONDARY outcome

Timeframe: Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation

Number of subjects responding to Burst and Tonic Stimulation defined as 30% or greater decrease in overall Visual Analog Scale (VAS) score from baseline. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.

Outcome measures

Outcome measures
Measure	Burst Stimulation n=100 Participants Burst Stimulation using the Prodigy system Burst Stimulation: Prodigy Neurostimulation System with associated components	Tonic Stimulation n=100 Participants Tonic Stimulation using the Prodigy system Tonic Stimulation: Prodigy Neurostimulation System with associated components
Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)	60 participants	51 participants

SECONDARY outcome

Timeframe: During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation

Population: There were 73 subjects in whom paresthesia coverage data at both the 12 and 24 week visits were available and included in the analysis. The remaining 23 subjects were excluded due to questionnaire completion errors at the time of data collection.

Paresthesia mapping (percentage of paresthesia coverage) analyzed to demonstrate the differences between Burst and Tonic Stimulation. Data is presented as areas of paresthesia reported while utilizing either Burst or Tonic Stimulation as a percentage of the total number of areas possible.

Outcome measures

Outcome measures
Measure	Burst Stimulation n=73 Participants Burst Stimulation using the Prodigy system Burst Stimulation: Prodigy Neurostimulation System with associated components	Tonic Stimulation n=73 Participants Tonic Stimulation using the Prodigy system Tonic Stimulation: Prodigy Neurostimulation System with associated components
Percentage of Paresthesia Coverage	4.5 Percentage of paresthesia areas Standard Deviation 8.7	22.7 Percentage of paresthesia areas Standard Deviation 16.3

SECONDARY outcome

Timeframe: Over 7 days after 3 months of treatment of burst or tonic stimulation

Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation to evaluate for superiority of Burst Stimulation. Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.

Outcome measures

Outcome measures
Measure	Burst Stimulation n=100 Participants Burst Stimulation using the Prodigy system Burst Stimulation: Prodigy Neurostimulation System with associated components	Tonic Stimulation n=100 Participants Tonic Stimulation using the Prodigy system Tonic Stimulation: Prodigy Neurostimulation System with associated components
Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation	43.5 mm Standard Deviation 25.6	48.7 mm Standard Deviation 23.9

Adverse Events

All Subjects

Serious events: 12 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Subjects n=100 participants at risk；n=173 participants at risk All subjects who were enrolled in the SUNBURST clinical study
Nervous system disorders Temporary paralysis	1.0% 1/100 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
General disorders Withdrawal symptoms from tapering off oxymorphone	1.0% 1/100 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
Injury, poisoning and procedural complications Persistent pain and/or numbness	0.58% 1/173 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
Injury, poisoning and procedural complications Unsuccessful lead placement	0.58% 1/173 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
Hepatobiliary disorders Abdominal pain	0.58% 1/173 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
Gastrointestinal disorders Bowel obstruction	0.58% 1/173 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
Injury, poisoning and procedural complications Femur fracture	0.58% 1/173 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
Surgical and medical procedures Hip pain/hip replacement	0.58% 1/173 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
General disorders Low Potassium Levels	0.58% 1/173 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancerous tumor on vocal chords	1.0% 1/100 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
Infections and infestations Infection	1.0% 1/100 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
Nervous system disorders Loss of speech and memory, and headache	1.0% 1/100 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
Surgical and medical procedures Scheduled right total knee arthroplasty	1.0% 1/100 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
Cardiac disorders Shortness of breath	1.0% 1/100 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
General disorders Somnolence	1.0% 1/100 • Number of events 1 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).

Other adverse events

Other adverse events
Measure	All Subjects n=100 participants at risk；n=173 participants at risk All subjects who were enrolled in the SUNBURST clinical study
General disorders Diminished or loss of symptom relief (Burst Stimulation)	5.0% 5/100 • Number of events 5 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
General disorders Diminished or loss of symptom relief (Tonic Stimulation)	6.2% 6/97 • Number of events 8 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).
General disorders Persistent pain and/or numbness	8.0% 8/100 • Number of events 8 • following enrollment through 6 months of treatment Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).

Additional Information

Roni Diaz, Director Clinical Studies

St. Jude Medical

Phone: 972-309-8601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER