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Идёт набор NCT04758624

Elucidating the Temporality of Structural and Functional Connectivity Changes in Essential Tremor After Successful Deep Brain Stimulation to the Dentato-rubro-thalamic Tract

Без фазы С лечением Essential Tremor

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: Deep Brain Stimulation.
Кому может быть актуально
Состояния в реестре: Essential Tremor. Базовые параметры: 18 лет — 85 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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Обзор

The purpose of this study is to elucidate the structural connectivity of the dentato-rubro-thalamic tract (DRTt) and to detect functional network changes due to DRTt stimulation

Вмешательства

  • Устройство Deep Brain Stimulation
    Medtronic Activa device will be implanted and administered clinically, except as part of the trial after 24 months of DBS being on it will be turned off for 3 days and will be turned back on.

Первичные конечные точки

  • Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI [Срок оценки: Baseline before DBS implant]
  • Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI [Срок оценки: 24 months after start of DBS]
  • Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI [Срок оценки: Baseline before DBS implant]
  • Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI [Срок оценки: 24 months after start of DBS]
  • Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI [Срок оценки: Baseline before DBS implant]
  • Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI [Срок оценки: 24 months after start of DBS]
  • Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI [Срок оценки: Baseline before DBS implant]
  • Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI [Срок оценки: 24 months after start of DBS]
  • Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI) [Срок оценки: Baseline before DBS implant]
  • Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI) [Срок оценки: 24 months after start of DBS]
Вторичные конечные точки (6)
  • Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA) [Срок оценки: Baseline before DBS implant]
  • Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA) [Срок оценки: 24 months after start of DBS]
  • Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA) [Срок оценки: Baseline before DBS is turned off]
  • Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA) [Срок оценки: 72 hours after DBS is turned off]
  • Tremor amplitude as assessed by accelerometric power [Срок оценки: Baseline before DBS is turned off]
  • Tremor amplitude as assessed by accelerometric power [Срок оценки: 72 hours after DBS is turned off]

Критерии участия

Критерии включения

  • the diagnosis of Essential Tremor, made by a movement disorder neurologist, where tremor is not secondary to any disease process or traumatic insult
  • distal appendicular tremor, with minimal proximal component
  • tremor refractory to multiple medication regimens and/or where the medications cause intolerable side effects
  • tremor judged to be severely impacting their quality of life.

Критерии исключения

  • significant neurological disorder
  • significant dementia or neurocognitive limitations as assessed by neuropsychiatry (when necessary)
  • severe psychiatric illness with suicidal ideations
  • previous surgery to destroy the target region of the brain
  • surgical contraindications to DBS
  • current major medical problems that affect brain anatomy,neurochemistry, or function, e.g., liver insufficiency, kidney insufficiency, cardiovascular problems, systemic infections, cancer, hypothyroidism, auto-immune diseases, and any current of history of brain disorder (seizure disorder, stroke, dementia, meningitis, encephalitis, degenerative neurologic diseases and head injury with loss of consciousness for any period of time)
  • family history of hereditary neurologic disorder, besides essential tremors ET
  • floating metallic objects in the body
  • pregnancy
  • alcohol or substance abuse/dependence in the past 6 months.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • North Shore University Hospital — Manhasset

Публикации

  • Conner CR, Forseth KJ, Lozano AM, Ritter R 3rd, Fenoy AJ. Thalamo-cortical evoked potentials during stimulation of the dentato-rubro-thalamic tract demonstrate synaptic filtering. Neurotherapeutics. 2024 Jan;21(1):e00295. doi: 10.1016/j.neurot.2023.10.005. Epub 2023 Dec 19. PMID 38237402

Идентификаторы

NCT: NCT04758624 · HSC-MS-20-0739

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗