Идёт набор NCT07680842
Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Target optimization using LIFU, Serial LIFU stimulation.
- Кому может быть актуально
- Состояния в реестре: Drug-Resistant Epilepsy, Epilepsy, Epilepsy (Treatment Refractory), Epilepsy Comorbidities. Базовые параметры: 21 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Pilot Study of Non-Invasive Low Intensity Focused Ultrasound as an Adjunctive Treatment for Drug-Resistant Epilepsy
Обзор
The goal of this study is to investigate the effects of a non-invasive, low intensity focused ultrasound (LIFU) stimulation on seizure frequency and the epileptogenic network in drug-resistant epilepsy. LIFU uses focused sound waves to modulate deep brain regions and to enable changes in brain network activity. Encephalography (EEG) and behavioral tasks will also be used to study how LIFU affects brain activity.
Вмешательства
- Устройство Target optimization using LIFU
LIFU will be administered using the ATTN201 wearable device by Attune Neurosciences Inc. Positioning is guided by an offline MRI scan, enabling non-invasive targeting of the LIFU beams directly to deep brain structures. Targeting will be determined based on the epileptogenic network. - Устройство Serial LIFU stimulation
Serial LIFU will again be administered using the ATTN201 wearable device by Attune Neurosciences Inc. Serial stimulation target selection will be based on the initial target optimization outcome, including the assessment of physiology and clinical treatment response.
Первичные конечные точки
- Seizure Frequency [Срок оценки: Seizure counts will be obtained daily for at least 1 month prior to the first study visit, throughout the study which averages around 4 months, and monitored for up to 2 months after the final visit.]
Вторичные конечные точки (2)
- LIFU induced network change based on fMRI and/or electrophysiology [Срок оценки: Obtained at the baseline visit and the final day of serial stimulation, which averages around 4 months.]
- Cognitive battery [Срок оценки: The cognitive battery will be performed at baseline visit, as well as at the beginning and end of routine study visits; the duration averages around a 4 month period.]
Критерии участия
Критерии включения
- Male or female between 21 and 65 years of age at screening
- Clinical diagnosis of drug-resistant epilepsy with on average, 4 or more seizures per month.
- Able to provide informed consent (or assent when applicable) by the subject or subject's legal representative.
- Be willing to undergo a brain MRI.
- Be able and willing to wear a headband during the treatment duration.
- Be able to complete scheduled visits and daily seizure logs.
Критерии исключения
- Has a craniotomy or pathologic intracranial lesion (e.g. vascular malformations) in the trajectory of the focused ultrasound beam.
- Pregnant, breastfeeding, is attempting pregnancy, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Has any unstable medical or psychiatric disease.
- Any contraindications for completing a brain MRI scan.
- Has evidence of any other clinically relevant neurological disorder at the time of screening, including Alzheimer's disease, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, and multiple sclerosis.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Одна группа
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- University of California, San Francisco — San Francisco
Публикации
- Fan JM, Woodworth K, Murphy KR, Hinkley L, Cohen JL, Yoshimura J, Choi I, Tremblay-McGaw AG, Mergenthaler J, Good CH, Pellionisz PA, Lee AM, Di Ianni T, Sugrue LP, Krystal AD. Thalamic transcranial ultrasound stimulation in treatment resistant depression. Brain Stimul. 2024 Sep-Oct;17(5):1001-1004. doi: 10.1016/j.brs.2024.08.006. Epub 2024 Aug 22. No abstract available. PMID 39173737
Идентификаторы
NCT: NCT07680842 · 24-41317