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This is a prospective, multi-center, non-significant risk IDE study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system. comprised of Medtronic hardware or off the shelf hardware, which uses recorded waveforms to adjust stimulation amplitude.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECAP Recording | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulator | Device | Spinal Cord Stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Collection of ECAP data (sensing configurations, stimulation parameters eliciting ECAPs, control policies/algorithms for recording ECAPs) via the research system. | The ECAP data collected is prototype system/device information for development of a closed loop system. | 1 hour to 72 hours |
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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 | ||
| MercyOne Des Moines Medical Center |
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| Des Moines |
| Iowa |
| 50314 |
| United States |
| Nura Research Institute | Edina | Minnesota | 55435 | United States |
| Twin Cities Pain Clinic | Edina | Minnesota | 55439 | United States |
| iSpine Pain Physicians | Maple Grove | Minnesota | 55369 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Kettering Health | 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 |
| Rockefeller Neuroscience Institute West Virginia University | Morgantown | West Virginia | 26505 | United States |
| 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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