Neuropathic Pain
Conditions
Brief summary
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.
Interventions
OTHERECAPS 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.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is at least 18 years of age. * Subject is able and willing to comply with the schedule and protocol. For implantation of DRG stimulator; * Subject has been diagnosed with complex regional pain syndrome (CRPS I or II). * Subject has had chronic, intractable pain of the groin or lower limbs for at least 6 months. * Subject is indicated for implantation of an Abbott DRG stimulation system. * Subject will be undergoing trial implantation of an Abbott DRG stimulation system. For implantation of SCS; * Subject has been diagnosed with chronic, intractable pain of the trunk and/or limbs. * Subject is indicated for implantation of a SCS system. * Subject will be undergoing implantation of an Abbott lead. * Subject has had stable neurologic function in the past 30 days. * Subject is able to provide informed consent.
Exclusion criteria
* Subject will be implanted with 3 or more DRG leads. * Subject is currently participating in a clinical investigation that includes an active treatment arm. * Subject has exhibited escalating or changing pain condition within the past 30 days as evidenced by physician examination. * Subject currently has an active implantable device including an ICD, pacemaker, spinal cord stimulator, or intrathecal drug pump. * Subject is a prisoner. * Female subject is pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain level as measured by pain scale | 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 | Visit 1, up to 2 hours | Evoked responses averaged across trials for ECAPS, measured in micro Volts |
| Evoked response amplitude for SSEPs | Visit 1, up to 2 hours | Evoked responses averaged across trials for SSEPs, measured in micro Volts |
Countries
United States
Outcome results
None listed