Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion

NCT03976219 | Terminated

• 1 other identifier: Pro00100055
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Evoked potentials of ECAPs and SSEPs

EXPERIMENTAL

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

Interventions

ECAPS Closed Loop SCS 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.

Evoked potentials of ECAPs and SSEPs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Viventi, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Nandan Lad, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 5, 2019
• Study Start: June 13, 2019
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)