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| ID | Type | Description | Link |
|---|---|---|---|
| CME AZ Delta | Other Identifier | 21083 | |
| Belgium registration number | Other Identifier | B1172021000026 |
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Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.
The study follow patients with chronic pain who received an EvokeTM spinal cord stimulator. The main aim of this study is to evaluate what influence different settings on nerve activation have and how this affects patients' sensation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECAP-controlled, closed-loop SCS | Device | Spinal cord stimulation 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 |
|---|---|---|
| Number of participants with change in stimulation sensation | Stimulation sensation will be characterized by study participants as better, worse or same for 5 different closed-loop sensitivity settings. | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| NRS | The numeric rating scale (NRS) is a pain screening tool. It is used to assess pain severity at that moment in time using a 0-10 scale. Zero meaning "no pain" and 10 meaning "the worst pain imaginable". | Baseline, 3-months, 6-months, 12-months post-implant |
| Number of participants with reduced pain distribution |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects suffering from chronic pain and are eligible for SCS trial and permanent implant.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karel Hanssens, Dr. | Contact | 0032 51 23 69 12 | ctc.pijn@azdelta.be |
| Name | Affiliation | Role |
|---|---|---|
| Karel Hanssens | AZ Delta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Delta | Recruiting | Roeselare | 8800 | Belgium |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Pain distribution will be assessed by showing a visual representation of the body that enables participants to indicate the locations of their pain. |
| Baseline, 3-months, 6-months and 12-months post-implant |
| Paraesthesia mapping | Paraesthesia mapping will be assessed by showing a visual representation of the body that enables participants to indicate the locations where they feel paraesthesia. | 3-months, 6-months and 12-months post-implant |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |