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

Primary Purpose

Neuropathic Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ECAPS Closed Loop SCS
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neuropathic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evoked potentials of ECAPs and SSEPs

Arm 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).

Outcomes

Primary Outcome Measures

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.
Evoked response amplitude for ECAPS
Evoked responses averaged across trials for ECAPS, measured in micro Volts
Evoked response amplitude for SSEPs
Evoked responses averaged across trials for SSEPs, measured in micro Volts

Secondary Outcome Measures

Full Information

First Posted
June 4, 2019
Last Updated
July 6, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03976219
Brief Title
Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion
Acronym
ECAPS SCS
Official Title
Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Budgetary Issues
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
December 9, 2021 (Actual)
Study Completion Date
December 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evoked potentials of ECAPs and SSEPs
Arm Type
Experimental
Arm 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).
Intervention Type
Other
Intervention Name(s)
ECAPS Closed Loop SCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain level as measured by pain scale
Description
Measured on a scale 0 to 10, with 0 being no pain and 10 being pain as bad as you can imagine.
Time Frame
Visit 1, up to 2 hours
Title
Evoked response amplitude for ECAPS
Description
Evoked responses averaged across trials for ECAPS, measured in micro Volts
Time Frame
Visit 1, up to 2 hours
Title
Evoked response amplitude for SSEPs
Description
Evoked responses averaged across trials for SSEPs, measured in micro Volts
Time Frame
Visit 1, up to 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Viventi, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nandan Lad, MD, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion

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