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Идёт набор NCT06529380

Deep Brain Stimulation for Severe Self-Injurious Behaviour in Children

Без фазы С лечением Self-Injurious Behavior Autism Spectrum Disorder

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: DBS ON, DBS OFF.
Кому может быть актуально
Состояния в реестре: Self-Injurious Behavior, Autism Spectrum Disorder. Базовые параметры: 5 лет — 17 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
Канада
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

A Randomized Trial of Deep Brain Stimulation of the Nucleus Accumbens for Severe Self-Injurious Behaviours in Children

Обзор

Deep Brain Stimulation for the Treatment of Severe Refractory Self-Injurious Behaviour in Children with Autism Spectrum Disorder: A Randomized Trial To evaluate the effectiveness of deep brain stimulation (DBS) of the nucleus accumbens for the treatment of severe refractory, repetitive self-injurious behavior (SIB) in children with Autism Spectrum Disorder. Secondary objectives are to examine the effects of DBS on subtypes of SIB through functional analysis.

Подробное описание

The proposed study is a single-center, double-blinded, block-randomized crossover trial.

Twenty-five (25) participants will be recruited and enrolled in this trial to undergo bilateral nucleus accumbens DBS. After recovery, participants will be randomized to a 3 month block of active stimulation or the DBS will remain off. After a two week washout period, the participants will cross over to the other group. At the end of the second block, all patients will have their DBS devices activated during an open label period. All participants will have baseline assessments that will be repeated at the end of each block.

Expected study duration is 24 months.

Вмешательства

  • Устройство DBS ON
    Electrical stimulation of the nucleus accumbens.
  • Устройство DBS OFF
    DBS will remain OFF (on at 0V).

Первичные конечные точки

  • Repetitive Behaviors Scale-Revised (RBS-R) [Срок оценки: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks]
Вторичные конечные точки (8)
  • Self-injurious behaviour log [Срок оценки: Baseline (3 months), weekly during trial]
  • Repetitive Behaviour Questionnaire-2 (RBQ-2) [Срок оценки: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks]
  • Self-Injurious Behavior Questionnaire (SIB-Q) [Срок оценки: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks]
  • Pediatric Quality of Life Inventory (PedsQL) Questionnaire [Срок оценки: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks]
  • Autism Diagnostic Observation Schedule (ADOS) Assessment questionnaire [Срок оценки: Baseline, 16 weeks, 30 weeks]
  • Modified Overt Aggression Scale (MOAS) questionnaire [Срок оценки: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks]
  • The Burden Scale for Family Caregivers - Short Version (BSFC-S) questionnaire [Срок оценки: Baseline, 4 weeks, 16 weeks, 30 weeks, 52 weeks]
  • Functional analysis (FA) assessment [Срок оценки: Baseline, 16 weeks, 30 weeks]

Критерии участия

Критерии включения

  • Age 5-17 at the time of enrollment
  • DSM-5 diagnosis of Autism Spectrum Disorder
  • History of repetitive self-injurious behaviour, as reported by parents and documented on clinical assessment, either at the time of enrollment into the study or in prior medical records. The definition of self-injury is contextual, but requires ongoing, intermittent or continuous manifestation of self-mediated physical injury to the child.
  • Foreseeable risk of serious future self-harm.
  • Screening by study team for presence automatically reinforced self-injurious behaviour (ASIB) subtype 2 or subtype 3 based on caregiver history.
  • Failure or non-eligibility of medical therapy with ongoing repetitive self-injurious behaviours, at 6 months or more after initiation of therapy.
  • Parents or legal guardians, including caregivers, informed and able to provide written consent.
  • Able to comply with all testing, follow-up visits, and study appointments and protocols for 12 months following the end of the duration of the study.

Критерии исключения

  • Substance dependence or abuse in the last 6 months, excluding caffeine and nicotine.
  • Any contraindication to MRI scanning.
  • Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions that may incur significant risk from a surgical procedure.
  • Pregnancy.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • The Hospital for Sick Children — Toronto

Публикации

  • Mithani K, Sauter S, Hagopian LP, Breitbart S, Sriharan S, Kisteroff F, Huynh M, Malik S, Thorpe KE, Huber J, Gorodetsky C, Ibrahim GM. Electrical Stimulation of the Nucleus Accumbens for Severe, Refractory Self-Injurious Behaviour in Children (EASE-SIB): protocol for a randomised double-blinded crossover trial. BMJ Open. 2026 Apr 20;16(4):e110222. doi: 10.1136/bmjopen-2025-110222. PMID 42009381

Идентификаторы

NCT: NCT06529380 · REB # 1000081171

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗