Trial Outcomes & Findings for Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial (NCT NCT04909593)
NCT ID: NCT04909593
Last Updated: 2024-12-06
Results Overview
Percent change in patient's perceiving spinal cord stimulation (i.e. Perception Threshold) when going from a reclining to sitting position in a reclining chair
COMPLETED
NA
21 participants
Programming Visit (up to 15 days post-screening)
2024-12-06
Participant Flow
Participant milestones
| Measure |
Spinal Cord Stimulation
SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.
Spinal Cord Stimulation: Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Spinal Cord Stimulation
SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.
Spinal Cord Stimulation: Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial
Baseline characteristics by cohort
| Measure |
Spinal Cord Stimulation
n=21 Participants
SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.
Spinal Cord Stimulation: Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, of African Heritage
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Programming Visit (up to 15 days post-screening)Population: Subjects who received programming with SCS trial neurostimulator system.
Percent change in patient's perceiving spinal cord stimulation (i.e. Perception Threshold) when going from a reclining to sitting position in a reclining chair
Outcome measures
| Measure |
Spinal Cord Stimulation
n=20 Participants
SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.
Spinal Cord Stimulation: Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters
|
|---|---|
|
Perception Threshold
|
157 percent change in perception threshold
Standard Deviation 52
|
Adverse Events
Spinal Cord Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sr. Director, Clinical Operations
Boston Scientific Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER