Electrically Evoked Compound Action Potentials Human Observation Medtronic System Study (ECHO-MDT)

Medtronic

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Spinal Cord Stimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT06499220

MDT19014

Details and patient eligibility

About

This is a prospective, multi-center, non-significant risk IDE study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system. comprised of Medtronic hardware or off the shelf hardware, which uses recorded waveforms to adjust stimulation amplitude.

Enrollment: 201 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 22 years of age or older
2. Candidate for or undergoing Medtronic SCS device trial for labeled indication*
3. Willing and able to provide signed and dated informed consent
4. Capable of comprehending and consenting in English
5. Willing and able to comply with all study procedures and visits *Candidate for or undergoing Medtronic SCS device trial for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic SCS trialing to treat the patient's chronic pain. This decision is to be made prior to discussing with the patient whether to enroll in the study.

Exclusion criteria

1. Implanted electrical cardiac device (e.g., pacemaker, defibrillator)
2. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)
3. Currently diagnosed with a disease that may confound ability to evoke compound action potentials, e.g. multiple sclerosis, as determined by the investigator
4. Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
5. Has untreated major psychiatric comorbidity, as determined by the investigator or designee
6. Trialed with a permanent implant lead and extension ("buried lead trial")

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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201 participants in 1 patient group

ECAP Recording

Experimental group

Treatment:

Device: Spinal Cord Stimulator