Diagnosing Epilepsy To EffeCT Change (DETECT)

Epiminder America, Inc.

Status and phase: Invitation-only; Phase 4

Conditions: Epilepsy (Treatment Refractory); Epilepsy

Treatments: Device: Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07110337

EM2401

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of focal and/or generalized epilepsy.
• Drug-resistant
• At least an average of 1 seizure within the past 3 months
• Participant completed a multi-day EEG assessment that was inconclusive, and is unchanged since the last EEG monitoring.

Exclusion criteria

• Epilepsy surgery within the past 6 months
• Active Deep Brain Stimulation (DBS) or Responsive Neurostimulator System (RNS)
• Participant needs treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI), Electro-Convulsive Therapy (ECT), lithrotripsy, and diathermy
• Participant cannot have surgery to have the device implanted

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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210 participants in 3 patient groups, including a placebo group

Minder System Treatment Arm

Experimental group

Treatment:

Device: Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system)

Minder System Control Arm

Placebo Comparator group

Treatment:

Device: Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system)

Standard of Care Arm

No Intervention group