Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion

Study Overview
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Brief Summary
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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.

Official Title
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Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Other: ECAPS Closed Loop SCS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evoked potentials of ECAPs and SSEPs<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |