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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-loop (OL) testing, then Closed-loop (CL) testing | Experimental | Subjects receive Open-loop testing, then Closed-loop testing (Spinal Cord Stimulation - SCS Therapy) |
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| Closed-loop testing, then Open-loop testing | Experimental | Subjects receive Closed-loop testing, then Open-loop testing (Spinal Cord Stimulation - SCS Therapy) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS) | Device | SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | In-clinic testing (1 day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Pain and Spinal Diagnostics | Carlsbad | California | 92009 | United States | ||
| Lakewalk Surgery Center |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2021 | Jan 26, 2024 |
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| Duluth |
| Minnesota |
| 55805 |
| United States |
| Nura Research Institute | Edina | Minnesota | 55435 | United States |
| Twin Cities Pain Clinic | Edina | Minnesota | 55439 | United States |
| The Ohio State University | Columbus | Ohio | 43203 | United States |
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
| Premier Pain Treatment Institute | Mount Orab | Ohio | 45154 | United States |
| Center for Interventional Pain and Spine | Lancaster | Pennsylvania | 17601 | United States |
| Innovative Pain Center | Watertown | South Dakota | 57201 | United States |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intent-to-treat (ITT) Analysis Set | Includes all subjects who were randomized. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Primary Indication for SCS | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | 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. | Posted | Count of Participants | Participants | In-clinic testing (1 day) |
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The extent of exposure in this study was defined as the time from in-clinic testing to subject discontinuation, which included the exposure to both the OL and CL in-clinic testing. The extent of exposure for all subjects was within 1 day.
Adverse events related to the ECHO-MDT system were collected during the study based on the investigator's assessment of the relationship to the ECHO-MDT system, procedure, or therapy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intent-to-treat (ITT) | Includes all subjects who were randomized. | 0 | 42 | 0 | 42 | 0 | 42 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janelle Blum | Medtronic | 262-289-8419 | janelle.blum@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 25, 2021 | Jan 26, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Unknown or Not Reported |
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| White |
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| American Indian or Alaska Native |
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| Failed Back Surgery Syndrome |
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| Multiple Back Operations |
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| Postlaminectomy Pain |
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| Radicular Pain Syndrome |
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