Medtronic Electrically Evoked Compound Action Potentials Human Observation Study
Clinical Trial & Research Study
Study Purpose
- The purpose of this study is to collect recordings of spinal cord signals (evoked waveforms, ECAPS) resulting from stimulation of the dorsal column at various postures and activities using a closed-loop system comprised of Medtronic hardware. Medtronic data collection systems automatically adjusts the amount of stimulation they give based on these signals. Information from this study will help Medtronic design new SCS systems in the future.
Medtronic ECHO-MDT study: A prospective, multi-center, non-significant risk investigational device exemption (IDE) study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system comprised of Medtronic hardware, which uses recorded waveforms to adjust stimulation amplitude.
- IRB Protocol #20192352
- Sponsor: Medtronic, Inc.
- The study will enroll up to 300 subjects from up to 40 sites in the United States
About the Study
In-Clinic testing visit will occur when the enrolled subject returns to clinic after their 7-day SCS trial for your lead removal. On this day, before your device leads are removed, you will be asked to perform postural changes and activities while data is collected. After this visit, your participation in the study will be over.
Can I Participate?
To be included in the study, you must meet these criteria (Inclusion Criteria):
- 22 years of age or older.
- Candidate for or undergoing Medtronic SCS device trial for labeled indication.
- Willing and able to comply with all study procedures and visits.
You may not be eligible for the study if you have any of these criteria (Exclusion Criteria):
- Implanted electrical cardiac devices (e.g., pacemaker, defibrillator).
- 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).
- Currently diagnosed with a disease that may confound ability to record evoked compound action potentials (examples: multiple sclerosis).
- Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study.
- Has untreated major psychiatric comorbidity, as determined by the investigator.
- Trialed with a permanent implant lead and extension (“buried lead trial”).