DETECT LTFU ? Diagnosing Epilepsy To EffeCT change Long-Term Follow-Up - Clinical Trial
¿Cuál es el Propósito de este estudio?
Taking part in this study can last up to two years after joining. People will have a first visit and then follow up visits every six months, for up to five visits total. These visits may happen in person, by phone, or by video. At each visit, the study team will check overall health, seizures, medicines, hospital stays, and any problems with the implanted device. They will also review information collected by the Minder device and ask people to answer questions about mood, memory, anxiety, and quality of life. Between visits, the study doctor may review device information each month as part of regular care. Some people may be asked to come in for extra visits if needed. No new surgery is required because the device was already placed before the study.
Epilepsy and Epilepsy Treatment Refractory
¿Quién puede participar en el Estudio?
People can join this study if they were part of an earlier study called DETECT and already had the Minder device placed in their body. They must have finished the DETECT study either by having an important seizure event or by completing the six month follow up visit. They must still have the Minder device implanted. They also must continue to meet the same health rules that were required for the DETECT study.
¿Qué Implica?
This study is being done to help doctors better understand and care for people with epilepsy whose seizures are hard to track with usual brain tests. Some people cannot use standard ways of watching seizures, so this study looks at how a device called the Minder System can help. The Minder System is already approved by the FDA and is not an experimental device. It helps collect information about seizures over time so doctors can make better treatment choices.
People who already took part in an earlier study and received the Minder device can join this study. The study will collect information about their general health, doctor visits, and how the information from the device helps with long term epilepsy care. Participants will continue seeing their regular doctor and will have checkups about every six months for up to two years after they received the device.
Detalles del Estudio
