Chronic Pain
Conditions
Brief summary
This is a prospective, multi-center, randomized, single-blind, cross-over, non-significant risk IDE research study to evaluate the in-clinic performance of a closed-loop algorithm in Spinal Cord Stimulation (SCS) therapy with an ENS device.
Interventions
DEVICEOpen-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)
SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm
Sponsors
MedtronicNeuro
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 22 years of age or older * Candidate for or undergoing Medtronic SCS device trial for labeled indication - Candidate for or undergoing a Medtronic SCS device trial for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic SCS trialing to treat the patient's chronic pain. This decision is to be made prior to discussing with the patient whether to enroll in the study * Willing and able to provide signed and dated informed consent * Capable of comprehending and consenting in English * Willing and able to comply with all study procedures and visits * Clear, measurable ECAP ECAPs - If during set up of the in-clinic testing, the subject does not have a clear, measurable ECAP (\>10uV amplitude obtained consistently and repeatably) they will not move forward with testing or randomization and will be considered a screen failure.
Exclusion criteria
* Implanted electrical cardiac devices (e.g., pacemaker, defibrillator) * Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee) * Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study * Has untreated major psychiatric comorbidity, as determined by the investigator or designee * Trialed with a permanent implant lead and extension (buried lead trial) * If subject is classified as vulnerable or requires a legally authorized representative (LAR)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Subjects With a Reduction in Overstimulation Sensation With SCS Using a Closed-loop Algorithm Compared With SCS in Open-loop | In-clinic testing (1 day) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intent-to-treat (ITT) Analysis Set Includes all subjects who were randomized. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Intent-to-treat (ITT) Analysis Set |
|---|---|
| Age, Continuous | 59.1 Years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Primary Indication for SCS Complex Regional Pain Syndrome | 0 Participants |
| Primary Indication for SCS Degenerative Disk Disease | 9 Participants |
| Primary Indication for SCS Failed Back Surgery Syndrome | 3 Participants |
| Primary Indication for SCS Multiple Back Operations | 0 Participants |
| Primary Indication for SCS Postlaminectomy Pain | 17 Participants |
| Primary Indication for SCS Radicular Pain Syndrome | 13 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants |
| Race/Ethnicity, Customized Black or African American | 5 participants |
| Race/Ethnicity, Customized Not Reported | 1 participants |
| Race/Ethnicity, Customized White | 35 participants |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
The Proportion of Subjects With a Reduction in Overstimulation Sensation With SCS Using a Closed-loop Algorithm Compared With SCS in Open-loop
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intent-to-treat (ITT) | 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 |
p-value: <0.001Binomial Exact Test