Purpose of this Study
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.
Who Can Participate?
Eligibility
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.
Age Range
18-75
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A prospective long-term follow-up study to evaluate the use of the Minder device to aid in treatment after actionable event identification in patients diagnosed
with epilepsy.
with epilepsy.
Principal Investigator
Shruti
Agashe
Protocol Number
PRO00119101
NCT ID
NCT07110454
Phase
N/A
Enrollment Status
Pending Open to Enrollment