Грация Лили Временное Вмешательство (SLEEP-TIES)
Использование временной интерференции для неинвазивного усиления гомеостаза сна у пациентов с эпилепсией
This study is to evaluate the effectiveness of targeted Transcranial Electrical Stimulation with Temporal Interference (TES-TI) interventions to boost Non-Rapid Eye Movement (NREM) sleep, decrease seizures and promote emotional health in patients with epilepsy. Up to 24 participants (8 control participants for technical optimization prior to recruitment and 16 patients with epilepsy) will be enrolled and can expect to be on study for up to 24 months.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This is a Phase I randomized, single-blind, cross-over feasibility study comprised of 16 participants. Each participant will undergo structural and functional MRI then complete four nights of TES-TI stimulation and four nights of sham stimulation in counterbalanced order, separated by ≥1 day between visits.
Conditions on each visit are randomized and counterbalanced. During each visit, participants will complete both the REST-Q and SSS questionnaires. Full HD-EEG will be applied as well as 4-16 stimulation electrodes. Participants will then undergo an emotion regulation task (face task) wherein they are presented with positive, negative, or neutral emotional stimuli.
This is followed by a resting HD-EEG recording, then overnight stimulation. Either sham or non-sham (8 patients in each group) stimuli will be applied at times during the sleep period. Upon waking, the same questionnaires and emotion regulation tasks will be completed.
Objectives:
- Assess the efficacy of TES-TI to boost sleep NREM slow-wave activity and spindles in patients with epilepsy overnight
- Assess the efficacy of TES-TI to improve sleep quality and mood (REST-Q) and sleepiness (sleepiness scale) after treatment (4 nights) vs. before
- Assess the efficacy of TES-TI to improve emotion responses (face task) and vigilance (psychomotor vigilance task; PVT) after treatment (4 nights) vs. before
- Assess the efficacy of TES-TI to improve restorative quality of sleep (REST-Q questionnaire) after treatment (4 nights) vs. before
- Assess the efficacy of TES-TI to reduce seizure frequency (self-reported) after treatment (4 nights) vs. before
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Melanie Boly, MD, PhD
- Номер телефона: 608-263-4338
- Электронная почта: boly@neurology.wisc.edu
Учебное резервное копирование контактов
- Имя: Beril Mat, MD
- Электронная почта: mat@wisc.edu
Места учебы
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Wisconsin
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Madison, Wisconsin, Соединенные Штаты, 53792
- UW School of Medicine and Public Health
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- English-speaking (able to provide consent and complete questionnaires)
- Citizen or holding permanent resident status
- History of refractory epilepsy with intractable seizures and/or cognitive decline
Exclusion Criteria:
- Any current or past history of neurological disorders or acquired neurological disease other than epilepsy (e.g. stroke, traumatic brain injury), including intracranial lesions
- Current history of poorly controlled headaches including intractable or poorly controlled migraines
- Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- Possible pregnancy or plan to become pregnant in the next 6 months
- Any metal in the head
- Any metal in the body
- Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
- Dental implants
- Permanent retainers
- Claustrophobia (a fear of small or closed places)
- Back problems that would prevent lying flat for several hours
- Regular night-shift work (second or third shift)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Sham Stimulation then Real Stimulation
Each participant will undergo structural and functional MRI then eight nights of intervention with possible sham or non-sham stimulation conditions. |
Real stimulation will take place on visits 2 - 5 or visits 6 - 10.
Другие имена:
Sham stimulation will take place on visits 2 - 5 or visits 6 - 10. After baseline night visit 1 and before intervention visits 2 - 10. MRI is used to help determine electrode placement.
Другие имена:
|
|
Экспериментальный: Real Stimulation then Sham Stimulation
Each participant will undergo structural and functional MRI then eight nights of intervention with possible sham or non-sham stimulation conditions. |
Real stimulation will take place on visits 2 - 5 or visits 6 - 10.
Другие имена:
Sham stimulation will take place on visits 2 - 5 or visits 6 - 10. After baseline night visit 1 and before intervention visits 2 - 10. MRI is used to help determine electrode placement.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
NREM Sleep Slow-Wave Activity Measured by High-Density EEG (delta power)
Временное ограничение: measured during 8 overnight visits, data collected up to 24 months on study
|
To assess the effect of TES-TI on NREM sleep slow-wave activity during treatment (4 nights) vs. sham (4 nights), slow-wave activity will be measured by high-density EEG. |
measured during 8 overnight visits, data collected up to 24 months on study
|
|
Number of Seizures per week
Временное ограничение: data collected at 4 time points up to 24 months on study, 1 month and 3 month follow up after completion of 4 nights treatment and 1 month and 3 month follow up after completion 4 nights sham condition
|
To assess the effect of TES-TI on incidence of seizures after treatment (4 nights) vs. sham (4 nights), participants will maintain a seizure diary. The self-reported number of seizures seizures per week for the first week and the first four-weeks post-intervention. |
data collected at 4 time points up to 24 months on study, 1 month and 3 month follow up after completion of 4 nights treatment and 1 month and 3 month follow up after completion 4 nights sham condition
|
|
Psychomotor Vigilance Task (PVT)
Временное ограничение: measured during 8 overnight visits, data collected up to 24 months on study
|
The vigilance task will be used to assess the effect of TES-TI on performance after treatment (4 nights) vs. sham (4 nights). This is a computerized reaction time task where a participant is presented with a fixation point on a computer screen. At random, the fixation point will change appearance at which point the participant is to click a provided button as quickly as possible. The time it took to respond is recorded automatically by the computer program and will be reported as the result. |
measured during 8 overnight visits, data collected up to 24 months on study
|
|
Restorative Sleep Questionnaire (REST-Q)
Временное ограничение: measured during 8 overnight visits, data collected up to 24 months on study
|
The REST-Q measure will be used to assess the effect of TES-TI on sleep quality and mood after treatment (4 nights) vs. sham (4 nights). It is a 9-item questionnaire assessing aspects of restorative sleep. Each item is scored on a 5-point Likert scale (1-light; 5-deep). Final scores are transformed to a scale of 0-100 here higher scores indicate more restorative sleep. |
measured during 8 overnight visits, data collected up to 24 months on study
|
|
Stanford Sleepiness Scale (SSS)
Временное ограничение: measured during 8 overnight visits, data collected up to 24 months on study
|
The Stanford Sleepiness Scale will be used to assess sleepiness after treatment (4 nights) vs. sham (4 nights). SSS is a measure of subjective alertness on a 7-point scale (total range of scores from 1-7). A lower score on the scale indicates higher alertness. |
measured during 8 overnight visits, data collected up to 24 months on study
|
|
Emotional Processing Task (Face Task): Percent Correct
Временное ограничение: measured during 8 overnight visits, data collected up to 24 months on study
|
The Face Task will be used to assess the effect of TES-TI on emotion response after treatment (4 nights) vs. sham (4 nights). This task involves viewing a series of emotionally charged images (60 positive, 60 negative, 60 neutral). |
measured during 8 overnight visits, data collected up to 24 months on study
|
|
Emotional Processing Task (Face Task): Percent Change in Reaction Time
Временное ограничение: measured during 8 overnight visits, data collected up to 24 months on study
|
The Face Task will be used to assess the effect of TES-TI on emotion response after treatment (4 nights) vs. sham (4 nights). This task involves viewing a series of emotionally charged images (60 positive, 60 negative, 60 neutral). |
measured during 8 overnight visits, data collected up to 24 months on study
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Melanie Boly, MD, PhD, UW School of Medicine and Public Health
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Неврологические проявления
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Эпилепсия
- Судороги
- Терапия
- Поведенческие дисциплины и деятельность
- Электрическая стимуляционная терапия
- Судорожная терапия
- Психиатрическая соматическая терапия
- Электрошок
- Психологические методы
- Транскраниальная стимуляция постоянного тока
Другие идентификационные номера исследования
- 2025-1852
- SMPH | NRL Neurology (Другой идентификатор: UW Madison)
- Protocol Version 2/17/26 (Другой идентификатор: UW Madison)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .