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The objective of this multicentre study is to collect electrophysiological and device data from the Evoke Closed-Loop SCS system in the treatment of chronic pain of the trunk and/or limbs, in a real world setting under normal conditions of use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECAP-controlled, closed-loop SCS | 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 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 |
|---|---|---|
| ECAP Measurement in Microvolts | Evoked Compound Action Potentials (ECAPs) as a measure of spinal cord activation | through 6 months post-implant |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female patients, age ≥ 18 years, suffering from chronic pain in the trunk and/or limbs, whom are implanted with the Saluda Medical Evoke SCS system.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universität Düsseldorf | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38954217 | Derived | Nijhuis H, Kallewaard JW, van de Minkelis J, Hofste WJ, Elzinga L, Armstrong P, Gultuna I, Almac E, Baranidharan G, Nikolic S, Gulve A, Vesper J, Dietz BE, Mugan D, Huygen FJPM. Durability of Evoked Compound Action Potential (ECAP)-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) in a Real-World European Chronic Pain Population. Pain Ther. 2024 Oct;13(5):1119-1136. doi: 10.1007/s40122-024-00628-z. Epub 2024 Jul 2. |
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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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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| D004358 |
| Drug Therapy |