Minder System for Epilepsy
(DETECT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the Minder System, a new tool for people with epilepsy whose seizures are difficult to track using regular methods. The Minder System, implanted under the scalp, aims to provide better seizure data by comparing its results to standard care. It targets individuals with drug-resistant epilepsy who have experienced at least one seizure in the past three months, particularly when previous EEG tests failed to provide clear answers. The goal is to determine if the Minder System can help doctors manage seizures more effectively. Participants will either have the Minder System implanted or continue with their usual care. As a Phase 4 trial, this research seeks to understand how the already FDA-approved Minder System benefits more patients.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop your current medications. It seems likely that you can continue your current treatment, as the study involves comparing the Minder System to standard care.
What is the safety track record for the Minder System?
Research has shown that the Minder System for epilepsy is safe for use. Earlier studies reported no serious problems or complications related to the device. The Minder System has received FDA De Novo authorization, indicating it is not experimental and meets specific safety standards. Participants in past studies managed the system well, and the brain wave monitoring (EEG) was as clear as with other methods. This demonstrates that the system functions as intended without causing harm.12345
Why are researchers enthusiastic about this study treatment?
The Minder System is generating excitement because it offers a novel approach to managing epilepsy. Unlike traditional treatments that often rely on medications to control seizures, the Minder System uses advanced technology to monitor brain activity and predict seizure occurrences, potentially reducing the need for medication. This method could lead to more precise and timely interventions, improving patient outcomes and quality of life. Researchers are eager to see if this system can provide a more personalized and proactive way to manage epilepsy, which could revolutionize current care practices.
What evidence suggests that the Minder System is effective for epilepsy?
Research has shown that the Minder System effectively tracks seizures over extended periods. One study found that it captures high-quality brain activity data, aiding doctors in understanding and managing epilepsy. The system has improved seizure tracking, addressing a significant gap in current technology. Clinical trials in top hospitals have confirmed its safety. The FDA has given it a special classification, underscoring its importance in epilepsy care. Participants in this trial may join the Minder System Treatment Arm to further evaluate its effectiveness and safety.23456
Are You a Good Fit for This Trial?
This trial is for individuals with epilepsy who average at least one seizure every three months, are resistant to medication, and have had inconclusive multi-day EEG assessments. It's not suitable for those who can't undergo implantation or don't meet the specific diagnostic criteria.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Device Implantation
Participants who choose the Minder device will have it implanted under their scalp
Blinded Monitoring
Participants are monitored with the Minder System, with some physicians having access to EEG data
Follow-up
Participants are monitored for safety and effectiveness after the main study period
What Are the Treatments Tested in This Trial?
Interventions
- Minder System
Trial Overview
The study tests the Minder System, an implantable device providing continuous EEG monitoring under the scalp. Participants will either receive this device or continue standard care. Some doctors will see their patients' Minder data; others won't know it until after the study.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Epiminder America, Inc.
Lead Sponsor
Citations
A first‐in‐human multicenter trial of bilateral subscalp ...
This study demonstrates the safety and performance of the Minder bilateral subscalp EEG acquisition system for long‐term seizure monitoring in ...
Early detection of antiseizure medication inefficacy using ...
Clinical outcomes. As per the International League Against Epilepsy, ASMs were efficacious if they achieved one year of seizure freedom or a seizure-free ...
Diagnosing Epilepsy To EffeCT Change Long-Term Follow ...
Study Overview This research is being done to understand how the Minder System helps physicians make decisions about participant's epilepsy treatment after an ...
4.
neurologylive.com
neurologylive.com/view/fda-grants-authorization-epiminder-implantable-continuous-eeg-monitor-epilepsy-treatmentFDA Grants Authorization to Epiminder's Implantable ...
“Minder can greatly improve seizure tracking and therefore seizure management. It will fill the significant gap in current EEG technologies, ...
Epiminder Announces Publication of Landmark Clinical ...
The study, conducted across leading Australian hospitals, demonstrated Minder's ability to capture high-quality EEG data for extended periods ...
Minder® System
Proven safety and effectiveness of Minder. The UMPIRE clinical study confirmed that the Minder System is both safe and effective for patients. With a high ...
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