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Идёт набор NCT05847985

Language and Lewy Body Diseases: Sentence Comprehension Problems and Modifying Noninvasive Brain Stimulation Treatment

Без фазы С лечением Lewy Body Disease Healthy Aging

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: transcranial direct current stimulation (tDCS).
Кому может быть актуально
Состояния в реестре: Lewy Body Disease, Healthy Aging. Базовые параметры: 60 лет — 80 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
Чехия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Lewy body diseases (LBDs) represents a group of neurodegenerative disorders characterized by the abnormal accumulation of aggregates of α-synuclein protein leading to the formation of Lewy bodies (LB) and Lewy neurites resulting in cell death. LBDs consists of two major clinical entities - Parkinson's disease (PD) and dementia with LB (DLB). Vast majority of patients with LBDs either already have mild cognitive impairment (MCI) at the time of the diagnosis or will develop it during the course of the disease. Language dysfunctions in LBDs patients with MCI are often unrecognized, which are difficult to treat, but even subtle changes might lead to impairment of social and occupational functioning with profound effect on their quality of lives. Current pharmacological or surgical strategies are effective for tackling the motor issues of LBDs with very limited effects on other symptoms such as language dysfunctions. Therefore, non-pharmacological approaches are gaining more attention. One of these non-pharmacological strategies is the use of noninvasive brain stimulation (NIBS) techniques that are able to modulate the brain functions with the effects on human nervous system plasticity. In this proposed project the investigators aim to first describe specific alterations in the language domain in LBDs patients with MCI as compared to healthy controls (HC) and identify the neural underpinnings of these changes using novel combination of advanced multimodal imaging techniques and various analytical methods. Secondly, the investigators aim to use NIBS as a supervised and individualized home-based therapeutical approach to tackle the language dysfunctions.

Вмешательства

  • Устройство transcranial direct current stimulation (tDCS)
    tDCS using electric currents to modulate underlying neurons

Первичные конечные точки

  • sentence comprehension performance - accuracy [Срок оценки: through study completion, an average of 1 year]
  • sentence comprehension performance - reaction times [Срок оценки: through study completion, an average of 1 year]
Вторичные конечные точки (9)
  • relation of sentence comprehension performance to cognitive performance [Срок оценки: through study completion, an average of 1 year]
  • The neural underpinning of sentence comprehension deficits - sentence comprehension fMRI task data [Срок оценки: through study completion, an average of 1 year]
  • The neural underpinning of sentence comprehension deficits - resting state data [Срок оценки: through study completion, an average of 1 year]
  • The neural underpinning of sentence comprehension deficits - structural MRI data [Срок оценки: through study completion, an average of 1 year]
  • the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - accuracy [Срок оценки: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment]
  • the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - reaction times [Срок оценки: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment]
  • the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - The neural underpinning of sentence comprehension deficits - resting state data [Срок оценки: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment]
  • the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - The neural underpinning of sentence comprehension deficits - sentence comprehension fMRI task data [Срок оценки: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment]
  • the long-term effects of repeated sessions of home-based tDCS on sentence comprehension - The neural underpinning of sentence comprehension deficits - structural MRI data [Срок оценки: On the beginning of the study, after completion of two-week stimulation a eight weeks after the baseline assessment]

Критерии участия

Критерии включения

  • right-handedness
  • Czech as their first language
  • age (60-80 years)
  • presence of PD-MCI (Litvan et al. 2012) or MCI-LB (McKeith et al. 2020) for LBD subjects

Критерии исключения

  • cardio pacemaker
  • any MRI-incompatible metal in the body
  • epilepsy
  • any diagnosed psychiatric disorders
  • alcohol/drug abuse
  • for HC group the presence of LBDs or other neurodegenerative disorder or MCI/dementia

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Чехия · 1 центр
  • Masaryk University CEITEC — Brno

Идентификаторы

NCT: NCT05847985 · NU23J-04-00005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗