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This trial is investigating the acceptability and efficacy of PFM-guided cortical stimulation for the treatment of central neuropathic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFM-guided cortical stimulation | Experimental | Abbott Eterna IPG and Lamitrode 44 paddles with accessory extensions and clinical programmers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PFM-guided cortical stimulation | Device | Abbott Eterna IPG and Lamitrode 44 paddles with accessory extensions and clinical programmers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Percentage of participants enrolled in the study who then undergo surgery and undergo externalized stimulation testing followed by implantation of the implantable pulse generator (IPG) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| NRS Pain Scale | Difference in numerical pain rating scale (NRS) between the best stimulation (sample of 5) and sham stimulation (sample of 5). Min-Max values: (0-10) where lower scores indicate a better outcome (more pain reduction) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Maple | Contact | 612-946-1424 | maple036@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Darrow, MD | University of Minnesota | Principal Investigator |
| Alexander Herman, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D051474 | Neuralgia, Postherpetic |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |