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Идёт набор NCT07690514

Theta Burst Transcranial Focused Ultrasound as a Novel Treatment for Cervical Dystonia

Без фазы С лечением Cervical Dystonia

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: LIFUS - GPi Active, LIFUS - DN Active, LIFUS - Sham.
Кому может быть актуально
Состояния в реестре: Cervical Dystonia. Базовые параметры: 18 лет — 90 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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Обзор

This study is a single-blinded, randomized control study that aims to recruit 48 participants. Participants will be "randomized" into one of the study arms of the study: active stimulation to GPi, active stimulation to DN, or sham stimulation. The purpose of the study is to look into the effects of LIFUS in patients with cervical dystonia. The participation will include seven study visits, at least 24 hours apart. All study visits will take place at TWH. The first visit is a screening visit. Visits 2-6 will be on consecutive days. Visit 7 will be a week from Visit 6 or from your last day of LIFUS, whichever comes first.

Подробное описание

Patients will be randomly assigned to one of three conditions (n =12 per condition): 1) bilateral tbLIFUS of the GPi, 2) bilateral tbLIFUS of the DN, and 3) bilateral sham tbLIFUS. Study participants will be randomized in a 1:1:1 fashion. In each group, the patients will receive tbLIFUS for five consecutive days. tbLIFUS will consist of two 120 s stimulation (one for each hemisphere, separated by 1 min). Visit 1 will consist of an anatomical MRI scan for each subject to allow accurate targeting of the GPi and DN, and for modelling the ultrasound distribution. Visit 2 will consist of baseline clinical assessments followed by pre-LIFUS rsfMRI. Immediately after, patients will receive tbLIFUS. Visits 3-5 will consist of tbLIFUS only. In Visit 6 (day 5 of stimulation), patients will receive tbLIFUS followed by rsfMRI and clinical assessments. In Visit 7, patients will undergo clinical assessments one week (+/- 3 days) after the last stimulation session in Visit 6. All patients and evaluators will be blinded to the stimulation condition. Visits 2-6 (stimulation days) will be conducted on five consecutive days. Outcome variables will be functional connectivity using rsfMRI, dystonia assessment (TWSTRS and DNMSQuest), cerebellar function assessment (Scale for the Assessment and Rating of Ataxia, SARA), head angle, tremor measurements, and phasic neck movements. SARA will be used in all conditions but will be primarily used to ensure that our protocol does not cause cerebellar dysfunction due to tbLIFUS of the DN. Tremor and phasic neck movements will be quantified with a three-axis accelerometer and neck angle will be measured using a goniometer. All clinical assessments will be video recorded and scored by two blinded movement disorders neurologists.

Вмешательства

  • Устройство LIFUS - GPi Active
    Bilateral thetaburst LIFUS stimulation to the globus pallidus
  • Устройство LIFUS - DN Active
    Bilateral thetaburst LIFUS stimulation to dentate nucleus
  • Устройство LIFUS - Sham
    Bilateral sham (placebo) LIFUS stimulation

Первичные конечные точки

  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [Срок оценки: from Visit 2 prior to stimulation to up to 2 weeks]
  • Resting State Functional MRI [Срок оценки: from Visit 2 prior to stimulation to up to 1 week]
  • Dystonia non-motor symptoms questionnaire (DNMSQuest) [Срок оценки: from Visit 2 prior to stimulation to up to 2 weeks]

Критерии участия

Критерии включения

  • 18 - 90 years of age
  • Confirmed diagnosis cervical dystonia
  • 3 months since last botulinum toxin injection
  • Stable medications in the past month

Критерии исключения

  • Has neurological disorder other than dystonia (such as compressive neuropathy, limb trauma, epilepsy)
  • Cognitive deficits leading to inability to understand study purposes and risks as well as the consent information without legal trustee
  • Presence of metal implanted in body that is contraindicated in MRI
  • Pregnancy
  • Has a previous surgical intervention to treat CD such as lesioning or a DBS system in place
  • Major systemic illness or infection

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
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Канада · 1 центр
  • Toronto Western Hospital — Toronto

Идентификаторы

NCT: NCT07690514 · 23-5741

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗