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Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study

NCT04765735 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-02-26

Study results available
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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

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

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-23
Primary Completion
2021-06-29
Completion
2021-06-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04765735 on ClinicalTrials.gov