At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effects of Novel SCS Paddle on Intraoperative Neuromonitoring Recording
In Brief
A clinical study evaluating HD Study Electrode for Chronic Pain and 3 related conditions. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.
Study Details
Timeline
Interventions
The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.