Wireless Spinal Cord Stimulation for Chronic Pain

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the effectiveness of the Stimwave Spinal Cord Stimulator (SCS) System for treatment of chronic pain

Clinical Trial Description

This is a multi-center, prospective study in which subjects will receive a Freedom SCS System and to receive stimulation at a frequency between 5 Hz to 1500 Hz . Enrollment will continue until 49 subjects have been implanted. Subjects will have chronic back or back and leg pain refractory to standard medical treatment associated with Failed Back Surgery Syndrome (FBSS). Subjects will be followed for a 6-month period after a maximum one-month trial period. At the end of 6 months follow-up, all subjects will assess the outcomes of their appointed therapy and continue with long-term use of the system. Stimulators will be placed at the following sites to target the painful area: • Epidural Space midline covering vertebrae levels T8 through T11 (one stimulator placed at the top of T8 and the second stimulator placed at the middle of T9). Paresthesia mapping will be utilised to determine the optimal location for stimulation of the painful area. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02514590
Study type	Interventional
Source	Stimwave Technologies
Contact
Status	Completed
Phase	N/A
Start date	July 2016
Completion date	July 2019

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