Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up

Official title

A Prospective Long-Term Follow-Up Study to Evaluate the Use of the Minder Device to Aid in Treatment After Actionable Event Identification in Patients Diagnosed With Epilepsy.

Overview

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.

Interventions

• Device 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.

Primary outcome measures

• 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]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 16 centers

• Mayo Clinic - Arizona — Phoenix
• Stanford — Palo Alto
• Stanford — Palo Alto
• Yale School of Medicine — New Haven
• Mayo Clinic - Florida — Jacksonville
• Nicklaus Children's Hospital — Miami
• USF Health — Tampa
• IU Health Neuroscience Center — Indianapolis
• … and 8 more centers

Publications

• 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 mon PMID 40445205

Identifiers

NCT: NCT07110454 · EM2402

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗