Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up

NCT ID: NCT07110454

Last Updated: 2026-02-02

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2029-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy Epilepsy (Treatment Refractory)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observational

Minder System

Previous receipt of the Minder System (implantable 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 until that continuously transmits these signals to the external Minder devices to remotely show EEGs for clinician review.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Previous receipt of the Minder System (implantable 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 until that continuously transmits these signals to the external Minder devices to remotely show EEGs for clinician review.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Epiminder America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic - Arizona

Phoenix, Arizona, United States

Site Status RECRUITING

Mayo Clinic - Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Washington University

St Louis, Missouri, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status ENROLLING_BY_INVITATION

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Epiminder, Director of Clinical Trials

Role: CONTACT

800-717-3185

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Neil Santos

Role: primary

480-301-4252

Frances Ortiz

Role: primary

904-953-2000

Colton Wright

Role: primary

617-975-8692

Sherry Klingerman

Role: primary

507-284-0451

Victoria Taylor, MD

Role: primary

314-362-7871

Johanna Sonnenschein

Role: backup

314-273-8861

References

Explore related publications, articles, or registry entries linked to this study.

Halliday AJ, Gillinder L, Lai A, Seneviratne U, Fontenot H, Cameron T, McLean K, Niemiec A, Raghupathi R, Ganguly TM, Ellis C, Conrad EC, Briggs R, Bulluss K, Kwan P, Perucca P, O'Brien TJ, McGonigal A, Gutman M, Papacostas J, Fong MWK, Lee A, Crompton DE, Laing J, Wijayath M, Morokoff AP, Murphy M, D'Souza WJ, Cook MJ. The UMPIRE study: A first-in-human multicenter trial of bilateral subscalp monitoring for epileptic seizure detection. Epilepsia. 2025 Sep;66(9):3426-3439. doi: 10.1111/epi.18458. Epub 2025 May 30.

Reference Type RESULT
PMID: 40445205 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EM2402

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ECV - Epihunter Clinical Validation
NCT04615442 COMPLETED NA
Human Intracranial Electrophysiology
NCT05529264 RECRUITING NA
Microelectrodes in Epilepsy
NCT05200455 COMPLETED NA
Subcutaneous EEG in Epilepsy
NCT02946151 COMPLETED NA
Localizing Epileptic Networks Using MRI and iEEG
NCT04649008 RECRUITING EARLY_PHASE1
SeizEAR Safety Study
NCT07088835 RECRUITING NA
Electrical Impedance Tomography of Epilepsy
NCT03050931 ACTIVE_NOT_RECRUITING