Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion (ECAPS SCS)
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|ClinicalTrials.gov Identifier: NCT03976219|
Recruitment Status : Suspended (Enrollment and in-person study activity suspended due to COVID-19)
First Posted : June 5, 2019
Last Update Posted : May 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain||Other: ECAPS Closed Loop SCS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion|
|Actual Study Start Date :||June 13, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Evoked potentials of ECAPs and SSEPs
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).
Other: ECAPS Closed Loop SCS
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.
- Pain level as measured by pain scale [ Time Frame: Visit 1, up to 2 hours ]Measured on a scale 0 to 10, with 0 being no pain and 10 being pain as bad as you can imagine.
- Evoked response amplitude for ECAPS [ Time Frame: Visit 1, up to 2 hours ]Evoked responses averaged across trials for ECAPS, measured in micro Volts
- Evoked response amplitude for SSEPs [ Time Frame: Visit 1, up to 2 hours ]Evoked responses averaged across trials for SSEPs, measured in micro Volts
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976219
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Jonathan Viventi, PhD||Duke University|
|Principal Investigator:||Nandan Lad, MD, PhD||Duke University|