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

Study Overview

• Status: Terminated
• Conditions: Neuropathic Pain
• Intervention / Treatment: Other: ECAPS Closed Loop SCS

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Thirakul, BS; Phone Number: 919-681-7601; Email: anna.thirakul@duke.edu
• Study Contact Backup: Name: Allison Spell, CCRP, AS; Phone Number: 919-681-4937; Email: allison.spell@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Jonathan Viventi, PhD, Duke University; Principal Investigator: Nandan Lad, MD, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Actual): December 9, 2021
• Study Completion (Actual): December 9, 2021

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: Pro00100055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No