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The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECAP-Controlled, Closed-Loop SCS | Experimental | Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evoke Spinal Cord Stimulation (SCS) System | Device | A spinal cord stimulation (SCS) system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System | physiological parameter to be measured = Evoked Compound Action Potentials (ECAPs); measurement tool = Evoke SCS System | through 6-months post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analogue Scale (VAS) Pain | Visual Analogue Scale (VAS) to rate pain intensity (0mm [no pain] to 100mm [worst pain imaginable]) | through 6-months post-implant |
| Change in PROMIS-29+2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lakeside Spine and Pain | Lake Havasu City | Arizona | 86403 | United States | ||
| Spanish Hills Interventional Pain Specialists |
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PROMIS-29 Profile and 2 PROMIS Cognitive Function Abilities items. The PROMIS-29 is a 29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity.
| through 6-months post-implant |
| Change in PROMIS-10 Global Health | 10-item instrument that assesses Physical Health and Mental Health | through 6-months post-implant |
| Camarillo |
| California |
| 93010 |
| United States |
| Pain Consultants of San Diego | La Mesa | California | 91942 | United States |
| Pacific Research Institute | Santa Rosa | California | 94104 | United States |
| Boomerang Healthcare | Walnut Creek | California | 94598 | United States |
| DBPS Research | Greenwood Village | Colorado | 80111 | United States |
| Pohlman Pain Associates | Delray Beach | Florida | 33445 | United States |
| Horizon Clinical Research | Jasper | Georgia | 30143 | United States |
| Rockford Pain Center | Rockford | Illinois | 61107 | United States |
| Goodman Campbell Brain and Spine | Carmel | Indiana | 46032 | United States |
| Metro Anesthesia & Pain Management | Des Moines | Iowa | 50317 | United States |
| Restorative Pain Institute | Louisville | Kentucky | 40241 | United States |
| Advanced Pain Institute | Hammond | Louisiana | 70403 | United States |
| Spine and Joint Institute | Glen Burnie | Maryland | 21061 | United States |
| Michigan Pain Specialists | Ann Arbor | Michigan | 48108 | United States |
| Pain Clinic of Michigan | Rochester Hills | Michigan | 48309 | United States |
| Tricity Research Center, LLC | Grand Island | Nebraska | 68803 | United States |
| Reno Tahoe Pain Associates | Reno | Nevada | 89509 | United States |
| Garden State Pain and Orthopedics | Clifton | New Jersey | 07013 | United States |
| Seaside Clinical Research Institute | Wilmington | North Carolina | 28412 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Premier Pain Treatment Institute | Loveland | Ohio | 45140 | United States |
| Carolinas Center for Advanced Management of Pain | Greenville | South Carolina | 29615 | United States |
| Institute of Precision Pain Medicine | Corpus Christi | Texas | 78414 | United States |
| Victoria Pain and Rehabilitation Center | Victoria | Texas | 77904 | 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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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004358 | Drug Therapy |
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