Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up

Официальное название

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.

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• 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. [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 16 центров

• 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
• … и ещё 8 центров

Публикации

• 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

Идентификаторы

NCT: NCT07110454 · EM2402

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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