Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion

Neuropathic Pain Clinical Trial

— ECAPS SCS  

Official title:

Measuring Evoked Potentials From the Spinal Cord and Dorsal Root Ganglion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03976219
• Other study ID #: Pro00100055
• Status: Terminated
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: December 9, 2021

Study information

• Verified date: July 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 9, 2021
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Evoked response amplitude for ECAPS	Evoked responses averaged across trials for ECAPS, measured in micro Volts	Visit 1, up to 2 hours
Primary	Evoked response amplitude for SSEPs	Evoked responses averaged across trials for SSEPs, measured in micro Volts	Visit 1, up to 2 hours