Vercise™ DBS Dystonia Prospective Study

Launched by BOSTON SCIENTIFIC CORPORATION · Feb 16, 2016

Keywords

ClinConnect Summary

The Vercise™ DBS Dystonia Prospective Study is a clinical trial designed to learn more about how well the Vercise™ Deep Brain Stimulation (DBS) Systems work for treating dystonia, a movement disorder that causes involuntary muscle contractions. Researchers want to gather information about the real-world experiences of patients using this device, which is already approved for use. The trial is currently recruiting participants, and anyone aged 7 years or older can join, as long as they meet specific guidelines for using the Vercise system. For younger participants, a parent or guardian must provide consent.

If you participate in this trial, you'll have the opportunity to contribute to important research that could help improve the treatment of dystonia for others. You will be part of a study that tracks your progress and outcomes while using the Vercise system. It's important to note that there are certain health conditions that may prevent someone from joining, as outlined in the study’s guidelines. Overall, this trial aims to better understand the benefits and effectiveness of the Vercise system for those living with dystonia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (IC):
• • IC1. Meets criteria established in the locally applicable Vercise System Directions for Use (DFU) for dystonia.
• • IC2. At least 7 years old. Parent or guardian consent is required in patients who are younger than 18 years at the time of consent.
• Exclusion Criteria (EC):
• • EC1. Meets any contraindication in the Vercise System locally applicable Directions for Use.