DETECT ? Diagnosing Epilepsy To EffeCT change - Clinical Trial
¿Cuál es el Propósito de este estudio?
Being in this study lasts up to ten months. After screening and joining, participants may choose to use the Minder device or receive regular epilepsy care only. People who choose the device will have a small brain monitoring device placed under the scalp. About two weeks later, they will receive a wearable device and a study phone. People using the device will then be placed by chance into one of two groups. In one group, the study doctor can look at the device information during the study. In the other group, the information is collected but not reviewed until the study is over. Everyone in the study will have follow up visits around one month and six months, answer questionnaires, review medicines, and track seizures. Some visits may happen by phone or video.
Epilepsy and Epilepsy (Treatment Refractory)
¿Quién puede participar en el Estudio?
People can join this study if they have epilepsy that affects one part of the brain or the whole brain. Their seizures do not get better with medicine, which means the epilepsy is hard to treat. They must have had at least one seizure on average in the last three months. They must also have already completed a long EEG test that did not clearly explain their seizures, and their condition has not changed since that test.
¿Qué Implica?
This study is being done to help doctors better diagnose and care for people with epilepsy whose seizures are hard to record with usual brain tests. Some people cannot use standard seizure monitors, so this study compares a device called the Minder System with regular epilepsy care. The Minder System is approved by the FDA and helps collect seizure information over time.
People who join the study can choose to have the Minder device placed under the scalp or continue with their usual epilepsy care. Those who get the device will have it implanted under the scalp. After that, they will be placed by chance into one of two groups. In one group, the doctor can see the brain data from the device during the study. In the other group, the data is collected but not shown to the doctor until the study ends. People who get the device will not know which group they are in. Everyone will keep seeing their regular doctor and will have study visits for up to six months to help decide the best treatment plan.
Detalles del Estudio
