Thalamus Seizure Detection With a Deep Brain Stimulator System

Официальное название

Seizure Detection With a Deep Brain Stimulation System

Обзор

The purpose of this study is to determine the feasibility of chronic ambulatory thalamus seizure detection. The sensitivity, specificity, and false alarm rate of thalamus seizure detection will be calculated using recordings from a deep brain stimulation system, assessed relative to concurrent gold-standard video-EEG monitoring collected in the in-patient setting (epilepsy monitoring unit), in 5 patients with drug resistant epilepsy.

Вмешательства

• Устройство Phase 1-Validation of thalamus seizure detection with concurrent video EEG monitoring
  Epilepsy monitoring unit evaluation will follow standard of care practices for seizure characterization, and antiseizure medications may be reduced to facilitate the recording of seizures. Patient clinical management, and video-EEG interpretation will be completed by the clinical epilepsy monitoring unit team which consists of physicians, nurse practitioners, registered nurses, and in-house 24-hour 7-days-per-week EEG technicians. Continuous full-bandwidth thalamus recordings (250 Hz) will be ac
• Устройство Phase 2-DBS Stimulation with Medtronic Percept DBS device-Out Patient
  Patients will then transition to the ambulatory phase. In the outpatient setting, patients will have constrained ambulatory thalamus recordings using recording parameters determined by Phase 1. DBS treatment stimulation will be programmed in the clinical epilepsy neuromodulation lab using typical high frequency (\>50 Hz) stimulation. High frequency stimulation is the conventional approach to DBS for epilepsy, as was used in the pivotal study leading to premarket approval (SANTE study)2 of anteri

Первичные конечные точки

• Thalamic seizure detection in the epilepsy monitoring unit [Срок оценки: 2 years]

Вторичные конечные точки (1)

• Ambulatory thalamus seizure detection with constrained DBS recordings [Срок оценки: 2 years]

Критерии участия

Критерии включения

Participants must meet all of the inclusion criteria to participate in this study:

• 18 years of age and older.
• Implanted with a clinical DBS system for epilepsy with brain recording capabilities (Medtronic Percept™ DBS).
• Subject or legally authorized representative is able to understand study procedures and to comply with them for the entire length of the study.

Критерии исключения

All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation:

• Health status or any clinical conditions (e.g., life expectancy, co-existing disease) that, in the opinion of the site investigator, would pose undue risk to undergo epilepsy monitoring unit evaluation for the purpose of seizure characterization.
• Women will verify not pregnant, and if applicable, have urine pregnancy test.
• Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT06700356 · 23-012058

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗