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Идёт набор NCT06425029

Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application

Без фазы С лечением Epilepsy Refractory Epilepsy Music

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: Experimental Intervention (Music A), Active Comparator Intervention (Music B), Active Comparator Intervention (Music C).
Кому может быть актуально
Состояния в реестре: Epilepsy, Refractory Epilepsy, Music. Базовые параметры: от 18 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 →
Официальное название

SONATA: Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application

Обзор

This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.

Подробное описание

This study aims to replicate and extend findings from prior electrophysiological studies that demonstrated a reduction in epileptiform discharges and seizures in patients living with drug-resistant (medications are not effective) epilepsy after listening to specific music.

It is believed to be the first study to examine the effect of daily, self-administered musical stimuli in reduction of epileptiform event detections over days to weeks. The study will enroll a cohort of patients already implanted with NeuroPace Responsive Neurostimulator (RNS) device to treat their epilepsy. This device uses continuous, outpatient electrocorticographic recording data to provide immediate (or 'responsive') closed loop neurostimulation.

Primary hypothesis is that patients with drug resistant epilepsy, implanted with RNS, will have fewer epileptic activity episodes (RNS 'long episodes') during the weeks of experimental music intervention. The study team expect to see improvement with daily listening to specific music intervention (experimental, Music A), but not with active comparators (Music B or C). The effect, if any, of music intervention is expected to last at least one week after the intervention period (block) (for each music piece) ends.

Secondary hypothesis is that the music listening every day will be associated with improved self-report of mood, quality of life, and self-reported measures of cognition. The study team suspects that this effect will not be limited to just one specific musical piece.

This study will also look to determine the feasibility of an at-home, self-administered auditory intervention in drug resistant epilepsy.

Вмешательства

  • Другое Experimental Intervention (Music A)
    Participants will be asked to listen to Music A on their personal device daily, at a time most convenient for them.
  • Другое Active Comparator Intervention (Music B)
    Participants will be asked to listen to music B on their personal device daily, at a time most convenient for them.
  • Другое Active Comparator Intervention (Music C)
    Participants will be asked to listen to music C on their personal device daily, at a time most convenient for them.

Первичные конечные точки

  • Music Intervention and its effects on epileptic activity in human brain [Срок оценки: Baseline, Week 3-4, Week 9-10, and Weeks 13-14, (Approximately 4 1/2 Months)]
Вторичные конечные точки (7)
  • Reduction in patient-reported seizures [Срок оценки: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)]
  • Determining duration of therapeutic effect of music intervention [Срок оценки: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)]
  • Assessment of pre- and post-intervention cognition scores (BRIEF-A) [Срок оценки: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)]
  • Assessment of pre- and post-intervention mood (DASS-21) [Срок оценки: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)]
  • Assessment of pre- and post-intervention quality of life (QOLIE-31) [Срок оценки: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)]
  • Assessment of music preferences pre- and post-intervention [Срок оценки: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)]
  • Assess feasibility of real-world, at home auditory stimulus interventions for patients with drug resistant epilepsy [Срок оценки: Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)]

Критерии участия

Критерии включения

  • Adults with medication-refractory focal epilepsy who have undergone RNS implantation at least six months prior and are in the judgement of the treating physician on a stable RNS regimen in terms of stimulation
  • Willing to attend all study visits and complete all required study procedures
  • Access to private or public wireless data service at regular intervals
  • Access to personal mobile device

Критерии исключения

  • Documentation of a musicogenic, or auditory-triggered focal seizure semiology
  • Participant is unable to reasonably participate in study tasks as determined by the investigator
  • Inability to obtain informed consent from the patient or legally authorized representative

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 2 центра
  • University of Massachusetts Chan Medical School — Worcester
  • Dartmouth-Hitchcock Medical Center — Lebanon

Публикации

  • Quon RJ, Casey MA, Camp EJ, Meisenhelter S, Steimel SA, Song Y, Testorf ME, Leslie GA, Bujarski KA, Ettinger AB, Jobst BC. Musical components important for the Mozart K448 effect in epilepsy. Sci Rep. 2021 Sep 16;11(1):16490. doi: 10.1038/s41598-021-95922-7. PMID 34531410
  • Feng Y, Quon RJ, Jobst BC, Casey MA. Evoked responses to note onsets and phrase boundaries in Mozart's K448. Sci Rep. 2022 Jun 10;12(1):9632. doi: 10.1038/s41598-022-13710-3. PMID 35688855

Идентификаторы

NCT: NCT06425029 · STUDY02002411

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗