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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03976219
Recruitment Status : Suspended (Enrollment and in-person study activity suspended due to COVID-19)
First Posted : June 5, 2019
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Other: ECAPS Closed Loop SCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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.




Primary Outcome Measures :
  1. Pain level as measured by pain scale [ Time Frame: 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.

  2. Evoked response amplitude for ECAPS [ Time Frame: Visit 1, up to 2 hours ]
    Evoked responses averaged across trials for ECAPS, measured in micro Volts

  3. Evoked response amplitude for SSEPs [ Time Frame: Visit 1, up to 2 hours ]
    Evoked responses averaged across trials for SSEPs, measured in micro Volts



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976219


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Jonathan Viventi, PhD Duke University
Principal Investigator: Nandan Lad, MD, PhD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03976219    
Other Study ID Numbers: Pro00100055
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms