Diagnosing Epilepsy To EffeCT Change

Официальное название

A Prospective Study to Evaluate the Use of the Minder Device to Aid in Developing a Treatment Plan After Inconclusive Prolonged EEG in Patients With Epilepsy

Обзор

The purpose of this research is to address the challenges of diagnosing and long-term management of 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 will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational. Participants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends. All participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit.

Вмешательства

• Устройство Receipt of the Minder System (implantable sub-scalp 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 unit that continuously transmits these signals to the external Minder devices to remotely show EEGs for clinician review.

Первичные конечные точки

• Compare the proportion of participants receiving the Minder System with those receiving Standard of Care (SOC) as a means of obtaining an actionable event based on clinical data (i.e. Minder EEG data, non-Minder EEG data, SOC assessments, etc.). [Срок оценки: 6 months]

Вторичные конечные точки (6)

• Compare the time to the first actionable event. [Срок оценки: 6 months]
• Compare participant wellbeing between groups with the Beck Depression Inventory (BDI) for symptoms associated with depression. [Срок оценки: 6 months]
• Compare participant wellbeing between groups with the Beck Anxiety Inventory (BAI) for symptoms associated with anxiety. [Срок оценки: 6 months]
• Compare healthcare utilization between groups by the number of hospital visits. [Срок оценки: 6 months]
• Compare healthcare utilization between groups by medication usage. [Срок оценки: 6 months]
• Compare healthcare utilization between groups by the number of surgeries or procedures. [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Diagnosis of focal and/or generalized epilepsy.
• Drug-resistant
• At least an average of 1 seizure within the past 3 months
• Participant completed a multi-day EEG assessment that was inconclusive, and is unchanged since the last EEG monitoring.

Критерии исключения

• Epilepsy surgery within the past 6 months
• Active Deep Brain Stimulation (DBS) or Responsive Neurostimulator System (RNS)
• Participant needs treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI), Electro-Convulsive Therapy (ECT), lithrotripsy, and diathermy
• Participant cannot have surgery to have the device implanted

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Диагностика

Центры проведения

США · 19 центров

• Mayo Clinic - Arizona — Phoenix
• University of California, Irvine Medical Center — Irvine
• 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 11 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: NCT07110337 · EM2401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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