Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Epiminder America, Inc.
Study ID
NCT07110454
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
210 participants (estimated)

Arms

  • Arm: Observational
    Minder System

Primary Outcome Measure

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 ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Mayo Clinic - ArizonaPhoenixArizona85054
Neil Santos
[email protected]
480-301-4252
Corneila Drees, M.D (PRINCIPAL_INVESTIGATOR)
Jonathon Parker, M.D., Ph.D. (SUB_INVESTIGATOR)
StanfordPalo AltoCalifornia94304
Adele Viviani
[email protected]
650-285-9180
Jessica Falco-Walter, MD (PRINCIPAL_INVESTIGATOR)
Yale School of MedicineNew HavenConnecticut06510
Danielle Carlson
[email protected]
612-594-4080
Aline Herlopian, M.D (PRINCIPAL_INVESTIGATOR)
Mayo Clinic - FloridaJacksonvilleFlorida32224
Frances Ortiz
[email protected]
904-953-2000
William Tatum, D.O. (PRINCIPAL_INVESTIGATOR)
USF HealthTampaFlorida33606
Marina Azevedo
[email protected]
813-250-2323
Ushtar Amin, MD (PRINCIPAL_INVESTIGATOR)
IU Health Neuroscience CenterIndianapolisIndiana46202-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Colton Wright
[email protected]
617-975-8692
Niravkumar Barot, MD, MPH (PRINCIPAL_INVESTIGATOR)
Mayo Clinic - RochesterRochesterMinnesota55905
Sherry Klingerman
[email protected]
507-284-0451
Brian Lundstrom, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63130
Victoria Taylor, MD
[email protected]
314-362-7871
Johanna Sonnenschein
[email protected]
314-273-8861
Robert Hogan, M.D (PRINCIPAL_INVESTIGATOR)
Atrium Health Neurosciences Institute - CharlotteCharlotteNorth Carolina28204
Gina M'Buyamba
[email protected]
704-355-9434
Rajdeep Singh, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
Kevin Hricik
[email protected]
216-286-5295
Nathaly Contreras Cisneros
[email protected]
216-844-2383
Michael Staudt, M.D. (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
T. Mindy Ganguly, MD
[email protected]
215-662-7227
T. Mindy Ganguly, M.D (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Mayo Clinic - Arizona· Phoenix, AZStanford· Palo Alto, CAYale School of Medicine· New Haven, CTMayo Clinic - Florida· Jacksonville, FLUSF Health· Tampa, FLIU Health Neuroscience Center· Indianapolis, IN

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