RNS® System Post-Approval Study in Epilepsy

  • STATUS
    Recruiting
  • participants needed
    10
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Updated on 19 February 2024

Summary


The RNS® System is an FDA approved medical device that monitors brain electrical activity and delivers brief pulses of stimulation when it detects activity that could lead to a seizure. The stimulation can help to prevent the seizure before it happens.  We are recruiting patients who are already planning to receive the device as part of their regular care.

 

The purpose of this study is to follow participants prospectively over 5 years in a real world environment to gather data on the long-term effectiveness and safety of the RNS® System. Your regular medical treatment will not be altered by your participation in this study.


Description

This is an observational study, which means that we are collecting information regarding the safety and efficacy of the RNS® System during its normal clinical use. The RNS® System is the only device being used in this study. The RNS® System has been studied and approved by the FDA, meaning that neither the device, nor the procedures are investigational. Being in the study will not affect how your RNS® System is managed.

FAQ


Details
Condition seizures,epilepsy
Age 18years - 99years
Clinical Study IdentifierTX6107
Last Modified on19 February 2024

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