Trials / Completed
CompletedNCT04765735
Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study
Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study (ECHO-MAC)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- MedtronicNeuro · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multi-center, randomized, single-blind, cross-over, non-significant risk IDE research study to evaluate the in-clinic performance of a closed-loop algorithm in Spinal Cord Stimulation (SCS) therapy with an ENS device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS) | SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm |
Timeline
- Start date
- 2021-02-23
- Primary completion
- 2021-06-29
- Completion
- 2021-06-29
- First posted
- 2021-02-21
- Last updated
- 2024-02-26
- Results posted
- 2024-02-26
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04765735. Inclusion in this directory is not an endorsement.