Diagnosing Epilepsy To EffeCT Change

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-23

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy Epilepsy (Treatment Refractory)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Minder System Treatment Arm

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

The Minder System consists of an implanted device containing an electrode lead and telemetry unit. The electrode lead contains four electrodes that are placed under the patient's scalp to record electrical activity (EEGs) from both sides of the brain. The electrode lead is connected to the telemetry unit that continuously transmits these signals to the external Minder devices to remotely show EEGs for clinician review.

Minder System Control Arm

Group Type PLACEBO_COMPARATOR

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

Intervention Type DEVICE

The Minder System consists of an implanted device containing an electrode lead and telemetry unit. The electrode lead contains four electrodes that are placed under the patient's scalp to record electrical activity (EEGs) from both sides of the brain. The electrode lead is connected to the telemetry unit that continuously transmits these signals to the external Minder devices to remotely show EEGs for clinician review.

Standard of Care Arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

The Minder System consists of an implanted device containing an electrode lead and telemetry unit. The electrode lead contains four electrodes that are placed under the patient's scalp to record electrical activity (EEGs) from both sides of the brain. The electrode lead is connected to the telemetry unit that continuously transmits these signals to the external Minder devices to remotely show EEGs for clinician review.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No