Minder System for Epilepsy

(DETECT Trial)

Overseen By Epiminder, Director of Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Epiminder America, Inc.

Disqualifiers: Epilepsy surgery, Active DBS, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational.

Participants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends.

All participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit.

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

My recent multi-day EEG test didn't clearly show what's wrong, and my condition hasn't changed since then.

I have been diagnosed with epilepsy.

My condition is resistant to standard treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Implantation

Participants who choose the Minder device will have it implanted under their scalp

1 week

1 visit (in-person)

Blinded Monitoring

Participants are monitored with the Minder System, with some physicians having access to EEG data

6 months

Regular visits as per physician's schedule

Follow-up

Participants are monitored for safety and effectiveness after the main study period

6 months

What Are the Treatments Tested in This Trial?

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?

Group I: Minder System Treatment Arm Experimental Treatment 1 Intervention

Group II: Standard of Care Arm Active Control 1 Intervention

Group III: Minder System Control Arm Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Epiminder America, Inc.

Lead Sponsor