Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion

Not Applicable

Terminated

• Conditions: Neuropathic Pain
• Interventions: Other: ECAPS Closed Loop SCS

• Registration Number: NCT03976219
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-05
• Study Start: 2019-06-13
• Primary Completion: 2021-12-09
• Study Completion: 2021-12-09
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evoked potentials of ECAPs and SSEPs	ECAPS Closed Loop SCS	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).

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States