Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves
This study is being done to see how well a new investigational medical device, the StimRouter System, will work to treat the chronic pain in people who have failed previous treatments for Carpal Tunnel Syndrome (CTS) pain, including surgery. These people have been treated for CTS pain before including surgical carpal tunnel release, but without good results, and they are still having pain. The study will look at both the good and bad effects of the StimRouter System for treating this kind of pain and as a general peripheral nerve stimulation device for treating chronic pain. The study will also help to understand other possible uses for the StimRouter System.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves|
- To evaluate the clinical use of the StimRouter, an implanted peripheral nerve stimulator system, for treating chronic peripheral pain using the median nerve as a general mode for that overall intended use. [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
- To provide a preliminary evaluation of the outcome measurements that maybe used to assess the clinical benefits related to the use of the StimRouter System as a peripheral nerve stimulator to treat chronic, intractable pain. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Device: StimRouter System
This is a prospective, single-center, open label study designed to evaluate the clinical use of the StimRouter as a peripheral nerve stimulation device for the treatment of chronic pain. The clinical study is proposed to serve as an evaluation of the preliminary StimRouter design, proposed implantation techniques, electrical stimulation parameters, and outcome measures for the StimRouter. The current study will utilize the median nerve (in the context of carpal tunnel syndrome (CTS), status-post a single failed carpal tunnel release (CTR) surgery)as a model to represent the device's more general intended use as a peripheral nerve stimulator to treat chronic pain.