Clinical trial NCT06499220: Electrically Evoked Compound Action Potentials Human Observation Medtronic System Study (ECHO-MDT)
Official title: Electrically Evoked Compound Action Potentials Human Observation Medtronic System Study (ECHO-MDT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2024-07-12
Enrollment: 201
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.


Eligibility criteria: 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")

Primary outcomes:
measure: Collection of ECAP data (sensing configurations, stimulation parameters eliciting ECAPs, control policies/algorithms for recording ECAPs) via the research system.
timeFrame: 1 hour to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Coastal Pain and Spinal Diagnostics
state: California
city: Des Moines
country: United States
facility: MercyOne Des Moines Medical Center
state: Iowa
city: Edina
country: United States
facility: Nura Research Institute
state: Minnesota
city: Edina
country: United States
facility: Twin Cities Pain Clinic
state: Minnesota
city: Maple Grove
country: United States
facility: iSpine Pain Physicians
state: Minnesota
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Kettering
country: United States
facility: Kettering Health
state: Ohio
city: Mount Orab
country: United States
facility: Premier Pain Treatment Institute
state: Ohio
city: Lancaster
country: United States
facility: Center for Interventional Pain and Spine
state: Pennsylvania
city: Morgantown
country: United States
facility: Rockefeller Neuroscience Institute West Virginia University
state: West Virginia
Study officials:
References: