Trial Outcomes & Findings for Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation (NCT NCT04073446)

NCT ID: NCT04073446

Last Updated: 2023-03-29

Results Overview

Change in pain intensity from Baseline to end of each Period (knee/foot). Pain scores are measured on a scale of 0 - 10 where 0 is no pain and 10 is maximum pain possible.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3 participants
• Primary outcome timeframe: up to 6 weeks
• Results posted on: 2023-03-29

Participant Flow

3 subjects were enrolled. However 2 were implanted and proceeded to crossover phase

Participant milestones

Measure	Subjects Received All Interventions (4 Programs) Four Programs utilized included DC perception and sub-perception; DR perception and subperception based programming
Overall Study STARTED	2
Overall Study DC Perception	2
Overall Study DR Perception	2
Overall Study DR Subperception	2
Overall Study DC Subperception	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Focal Pain Outcomes Using Configurations Applied for Lateral Stimulation

Baseline characteristics by cohort

Measure	Subjects Received 4 Interventions (4 Programs) n=2 Participants Four Programs utilized included DC perception and sub-perception; DR perception and subperception based programming
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 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	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 weeks

Change in pain intensity from Baseline to end of each Period (knee/foot).

Pain scores are measured on a scale of 0 - 10 where 0 is no pain and 10 is maximum pain possible.

Outcome measures

Measure	Dorsal Column (DC) Perception n=2 Participants Use of DC Perception based programming Spinal Cord Stimulation: Patients eligible for SCS	Dorsal Root (DR) Perception n=2 Participants Use of DR Perception based programming Spinal Cord Stimulation: Patients eligible for SCS	Dorsal Root (DR) Sub-perception n=2 Participants Use of DR sub-perception based programming Spinal Cord Stimulation: Patients eligible for SCS	Dorsal Column (DC) Sub-perception n=1 Participants Use of DC sub-perception based programming Spinal Cord Stimulation: Patients eligible for SCS
Change in Pain Intensity	5 units on a scale Interval 4.0 to 6.0	4.5 units on a scale Interval 2.0 to 7.0	4.5 units on a scale Interval 2.0 to 7.0	1 units on a scale Interval 1.0 to 1.0

Adverse Events

Dorsal Column (DC) Perception

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dorsal Root (DR) Perception

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Dorsal Column (DC) Sub-perception

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Dorsal Root (DR) Sub-perception

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dorsal Column (DC) Perception n=2 participants at risk Use of DC Perception based programming Spinal Cord Stimulation: Patients eligible for SCS	Dorsal Root (DR) Perception n=2 participants at risk Use of DR Perception based programming Spinal Cord Stimulation: Patients eligible for SCS	Dorsal Column (DC) Sub-perception n=1 participants at risk Use of DC sub-perception based programming Spinal Cord Stimulation: Patients eligible for SCS	Dorsal Root (DR) Sub-perception n=2 participants at risk Use of DR sub-perception based programming Spinal Cord Stimulation: Patients eligible for SCS
Musculoskeletal and connective tissue disorders Shoulder Pain	0.00% 0/2 • Adverse events were collected and reported up to end of crossover phase (approximately 18 weeks)	0.00% 0/2 • Adverse events were collected and reported up to end of crossover phase (approximately 18 weeks)	0.00% 0/1 • Adverse events were collected and reported up to end of crossover phase (approximately 18 weeks)	50.0% 1/2 • Number of events 1 • Adverse events were collected and reported up to end of crossover phase (approximately 18 weeks)

Other adverse events

Measure	Dorsal Column (DC) Perception n=2 participants at risk Use of DC Perception based programming Spinal Cord Stimulation: Patients eligible for SCS	Dorsal Root (DR) Perception n=2 participants at risk Use of DR Perception based programming Spinal Cord Stimulation: Patients eligible for SCS	Dorsal Column (DC) Sub-perception n=1 participants at risk Use of DC sub-perception based programming Spinal Cord Stimulation: Patients eligible for SCS	Dorsal Root (DR) Sub-perception n=2 participants at risk Use of DR sub-perception based programming Spinal Cord Stimulation: Patients eligible for SCS
Musculoskeletal and connective tissue disorders Fasciculation	0.00% 0/2 • Adverse events were collected and reported up to end of crossover phase (approximately 18 weeks)	0.00% 0/2 • Adverse events were collected and reported up to end of crossover phase (approximately 18 weeks)	100.0% 1/1 • Number of events 1 • Adverse events were collected and reported up to end of crossover phase (approximately 18 weeks)	0.00% 0/2 • Adverse events were collected and reported up to end of crossover phase (approximately 18 weeks)
Gastrointestinal disorders No bowel movements	0.00% 0/2 • Adverse events were collected and reported up to end of crossover phase (approximately 18 weeks)	50.0% 1/2 • Number of events 1 • Adverse events were collected and reported up to end of crossover phase (approximately 18 weeks)	0.00% 0/1 • Adverse events were collected and reported up to end of crossover phase (approximately 18 weeks)	0.00% 0/2 • Adverse events were collected and reported up to end of crossover phase (approximately 18 weeks)

Additional Information

Roshini Jain, Sr. Director Clinical Sciences

Boston Scientific

Phone: 16619494350

Email: roshini.jain@bsci.com

Results disclosure agreements

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