Not provided
Not provided
Not provided
Not provided
Budgetary Issues
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the feasibility of recording evoked compound action potentials (ECAPs) and somatosensory evoked potentials (SSEPs) from the spinal cord (SC) and Dorsal root ganglions (DRG), and their suitability as feedback signals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evoked potentials of ECAPs and SSEPs | Experimental | Patients implanted with a spinal cord stimulator. In this arm, we are measuring the evoked potentials of electric compound action potentials (ECAPs) and somatosensory evoked potentials (SSEPs). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECAPS Closed Loop SCS | Other | The purpose of this study is to determine the feasibility of recording evoked compound action potentials (ECAPs) and somatosensory evoked potentials (SSEPs) from the spinal cord (SC) and Dorsal root ganglions (DRG), and their suitability as feedback signals. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain level as measured by pain scale | Measured on a scale 0 to 10, with 0 being no pain and 10 being pain as bad as you can imagine. | Visit 1, up to 2 hours |
| Evoked response amplitude for ECAPS | Evoked responses averaged across trials for ECAPS, measured in micro Volts | Visit 1, up to 2 hours |
| Evoked response amplitude for SSEPs | Evoked responses averaged across trials for SSEPs, measured in micro Volts | Visit 1, up to 2 hours |
Not provided
Not provided
Inclusion Criteria:
For implantation of DRG stimulator;
For implantation of SCS;
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Viventi, PhD | Duke University | Principal Investigator |
| Nandan Lad, MD, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |