Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion (ECAPS SCS)

Duke University

Status: Terminated

Conditions: Neuropathic Pain

Treatments: Other: ECAPS Closed Loop SCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03976219

Pro00100055

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Evoked potentials of ECAPs and SSEPs

Experimental group

Description:

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).

Treatment:

Other: ECAPS Closed Loop SCS