Health TrialsbyHealthPanel

Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up

ConditionsEpilepsyEpilepsy (Treatment Refractory)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorEpiminder America, Inc.

About this trial

The purpose of this research is to address the challenges of correctly monitoring, managing, and diagnosing 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 is being done to understand how the Minder System helps physicians make decisions about participant's epilepsy treatment after an actionable event. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational.

Participants that have completed the DETECT study and received the Minder System previously will consent to join this long-term follow-up observational study. The study will collect information about general wellbeing, use of healthcare services, and experience using the Minder data over time to support long-term epilepsy care.

All participants will continue to be followed by their treating physician and undergo assessments and visits every six (6) months until two (2) years after receiving the Minder device.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant met all inclusion criteria, was enrolled in the DETECT study, and received the Minder device

Participant completed the DETECT study by receiving an actionable event or by completing the 6-month follow-up visit

Participant continues to have the Minder device implanted

Participant must continue to meet relevant DETECT study inclusion criteria

Disqualifiers

Participant meets any relevant DETECT study exclusion criteria including needing treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI)

Trial population

Participants previously implanted with the Minder device

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Previous receipt of the Minder System (implantable continuous electroencephalographic (EEG) monitoring (iCEM) system)

    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 until that continuously transmits these signals to the external Minder devices to remotely show EEGs for clinician review.

Treatment groups

210 Participants
are divided into 1 treatment group
Group A: Observational1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the Minder System to aid in treatment following an actionable event by comparing change using the Patient Global Impression scale (PGIC) from baseline to follow-up.

Time frame
2 years

Secondary outcomes

Other outcomes

1

To evaluate the Minder System to aid in treatment following an actionable event by comparing change using Clinician Global Impression scale (CGIC) from baseline to follow-up.

Time frame
2 years
2

To evaluate the Minder System to aid in treatment following an actionable event by comparing quality of life using the EQ-5D from baseline to follow-up.

Time frame
2 years
3

To evaluate the Minder System to aid in treatment following an actionable event by comparing healthcare utilization by number of surgeries or procedures.

Time frame
2 years
4

To evaluate the Minder System to aid in treatment following an actionable event by comparing healthcare utilization by medication usage.

Time frame
2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Epiminder America, Inc.

Lead sponsor

Source ClinicalTrials.gov
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