Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion

NCT ID: NCT03976219

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-13
• Study Completion Date: 2021-12-09

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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

ECAPS Closed Loop SCS

Intervention Type: OTHER

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

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Viventi, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Nandan Lad, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00100055

Identifier Type: -

Identifier Source: org_study_id