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Идёт набор NCT06323278

Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease

— Наблюдательное Parkinson Disease

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: Cognitive training.
Кому может быть актуально
Состояния в реестре: Parkinson Disease. Базовые параметры: 18 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
Италия
Следующий шаг
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Официальное название

Evaluation of the Cognitive Stimulation Treatment in Patients With Parkinson's Disease

Обзор

The goal of this observational study is to evaluate the relationship between GBA mutation and cognitive stimulation treatment response in patients with Parkinson's disease. The main questions it aim to answer are: • assess whether the GBA mutation is associated with greater or lesser response to cognitive training treatment compared to a control group of PD patients without genetic mutations. • investigate the effect of cognitive stimulation program on behavioural aspects as secondary consequence induced by the possible improvement of cognitive abilities following treatment. Participants will be undergo to: - a neuropsychological evaluation describing their cognitive profile; - a genetic investigation and finally included in a cognitive stimulation programs according to regular clinical practice. Researchers will compare PD patients with GBA mutation and patients without genetic mutation to evaluate the effectiveness of cognitive stimulation treatment.

Вмешательства

  • Поведенческое Cognitive training
    The training, provided by normal clinical practice, will consist of two cycles of cognitive stimulation (8 sessions each) structured and aimed at maintaining and learning compensatory strategies that take advantage of the integrated cognitive skills.

Первичные конечные точки

  • Efficacy of the cognitive training on cognitive function in PD patients with GBA mutation compared to a control group of PD patients without genetic mutations. [Срок оценки: Baseline and Six months follow-up post cognitive training]
Вторичные конечные точки (8)
  • The effect of cognitive training on behavioural aspects in PD patients. [Срок оценки: Baseline and Six months follow-up post cognitive training]
  • The effect of cognitive training on behavioural aspects in PD patients. [Срок оценки: Baseline and Six months follow-up post cognitive training]
  • The effect of cognitive training on behavioural aspects in PD patients. [Срок оценки: Baseline and Six months follow-up post cognitive training]
  • The effect of cognitive training on behavioural aspects in PD patients. [Срок оценки: Baseline and Six months follow-up post cognitive training]
  • The effect of cognitive training on behavioural aspects in PD patients. [Срок оценки: Baseline and Six months follow-up post cognitive training]
  • The effect of cognitive training on behavioural aspects in PD patients. [Срок оценки: Baseline and Six months follow-up post cognitive training]
  • The effect of cognitive training on behavioural aspects in PD patients. [Срок оценки: Baseline and Six months follow-up post cognitive training]
  • The effect of cognitive training on behavioural aspects in PD patients. [Срок оценки: Baseline and Six months follow-up post cognitive training]

Критерии участия

Критерии включения

  • Patients with Parkinson's disease according to the Gelb et al. criteria;
  • Patients who have carried out genetic screening for MP;
  • Patients who have a raw score in the range 15.50 to 22.23 at Montreal cognitive assessment (MoCA);
  • Patients who have signed the informed consent and the Privacy Policy;
  • Patients who are included in cognitive stimulation programs according to regular clinical practice.

Критерии исключения

  • Patients with the initial suspicion of MP that during the diagnostic work-up they were suffering from a different pathology;
  • Patients who have refused consent to participate in the study;
  • Patients with a diagnosis of MP and cognitive profile of dementia;
  • Patients undergoing deep brain neurostimulation (DBS-STN) treatment. Patients treated with DBS-STN were excluded because such treatment involves a surgical procedure whose effects on cognitive functioning could represent an interfering variable.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan

Идентификаторы

NCT: NCT06323278 · PD&REHAB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗