Trial Outcomes & Findings for Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study (NCT NCT04765735)
NCT ID: NCT04765735
Last Updated: 2024-02-26
Results Overview
For every overstimulation sensation brought about by protocol-prescribed activities, subjects will rate the intensity of the sensation using a 5-point Likert scale. The average intensity score during OL and CL periods will be calculated for each subject. If the average intensity score during CL period is less than that from the OL period, the subject is considered as a subject with a reduction in overstimulation sensation during CL vs. OL period. The primary endpoint is the proportion of subjects with a reduction in overstimulation sensation among subjects who have in-clinic testing.
COMPLETED
NA
52 participants
In-clinic testing (1 day)
2024-02-26
Participant Flow
Subjects were randomized at the In-Clinic Testing Visit following their Enrollment/Baseline Visit (consent visit). Ten Subjects exited the study prior to randomization resulting in 42 subjects that were randomized.
Participant milestones
| Measure |
Open-loop Testing, Then Closed-loop Testing
Subjects receive Open-loop testing, then Closed-loop testing (Spinal Cord Stimulation - SCS Therapy)
Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS): SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm
|
Closed-loop Testing, Then Open-loop Testing
Subjects receive Closed-loop testing, then Open-loop testing (Spinal Cord Stimulation - SCS Therapy)
Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS): SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
|
Overall Study
COMPLETED
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study
Baseline characteristics by cohort
| Measure |
Intent-to-treat (ITT) Analysis Set
n=42 Participants
Includes all subjects who were randomized.
|
|---|---|
|
Age, Continuous
|
59.1 Years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
35 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
|
Primary Indication for SCS
Complex Regional Pain Syndrome
|
0 Participants
n=5 Participants
|
|
Primary Indication for SCS
Degenerative Disk Disease
|
9 Participants
n=5 Participants
|
|
Primary Indication for SCS
Failed Back Surgery Syndrome
|
3 Participants
n=5 Participants
|
|
Primary Indication for SCS
Multiple Back Operations
|
0 Participants
n=5 Participants
|
|
Primary Indication for SCS
Postlaminectomy Pain
|
17 Participants
n=5 Participants
|
|
Primary Indication for SCS
Radicular Pain Syndrome
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: In-clinic testing (1 day)Population: Intent-to-treat analysis set included all subjects who were randomized. Analysis was pre-specified in the study statistical analysis plan to report out on the total proportion of subjects with success together, regardless of the randomization sequence.
For every overstimulation sensation brought about by protocol-prescribed activities, subjects will rate the intensity of the sensation using a 5-point Likert scale. The average intensity score during OL and CL periods will be calculated for each subject. If the average intensity score during CL period is less than that from the OL period, the subject is considered as a subject with a reduction in overstimulation sensation during CL vs. OL period. The primary endpoint is the proportion of subjects with a reduction in overstimulation sensation among subjects who have in-clinic testing.
Outcome measures
| Measure |
Intent-to-treat (ITT)
n=42 Participants
Includes all subjects who were randomized.
|
|---|---|
|
The Proportion of Subjects With a Reduction in Overstimulation Sensation With SCS Using a Closed-loop Algorithm Compared With SCS in Open-loop
|
41 Participants
|
Adverse Events
Intent-to-treat (ITT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Per the Clinical Investigation Plan: All proposed publications must be reviewed and approved by Medtronic prior to publication. If required by a publisher, the principal investigator agrees to obtain all necessary authorizations from study subjects prior to submitting study-related information for publication.
- Publication restrictions are in place
Restriction type: OTHER