Testing the Feasibility of Computer-based Cognitive Training in Individuals with Multiple Sclerosis Living in the Community
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: Learning and memory training, Sham Comparator.
- Кому может быть актуально
- Состояния в реестре: Multiple Sclerosis. Базовые параметры: 19 лет — 65 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
Cognitive impairments are common in multiple sclerosis (MS) diagnosed both at the onset and throughout the disease course. Poor cognitive abilities have been associated with poor outcomes such as higher levels of unemployment, poor quality of life, driving difficulties among others. Learning and memory are a common cognitive deficit. This computer-based cognitive training is a 10-session treatment proven to be effective in ameliorating learning and memory in individuals with MS across 3 realms of functioning: objective cognitive performance, daily life activities and neuroimaging. Despite this strong efficacy, as well as the recent clinical application of this computer-based cognitive training across the world, recent in-person studies have highlighted that transportation to the clinic to complete treatment sessions is a significant obstacle to clinical use of this effective treatment. To address this limitation, the proposed pilot study will test the efficacy of the computer-based cognitive training administered remotely via zoom health in persons with multiple sclerosis.
Вмешательства
- Поведенческое Learning and memory training
The experimental group will receive memory retraining exercises administered on a laptop computer via Zoom Health twice a week for five weeks (10 training sessions). - Поведенческое Sham Comparator
The sham comparator group will receive sham memory exercises administered on a laptop computer via Zoom Health twice a week for five weeks (10 placebo control sessions).
Первичные конечные точки
- California Learning Verbal Test III [Срок оценки: Primary outcome will be assessed at baseline (1 week before training start) and immediate follow-up (within 1 week after training completion)]
Вторичные конечные точки (1)
- Ecological Memory Simulations [Срок оценки: Secondary outcome will be assessed at baseline (1 week before training start) and immediate follow-up (within 1 week after training completion)]
Критерии участия
Критерии включения
- English as primary language
- Diagnosis of multiple sclerosis
Критерии исключения
- Most recent exacerbation within one month
- Other Neurological History: head injury, stroke, seizures, or any other significant neurological history will not be included in the study
- Individuals with an active diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II will be excluded from the study.
- Poor Visual Acuity (corrected vision in worse eye \< 20/60), diplopia, or nystagmus
- Inability to understand directions and following one, two, and three step commands
- Intact New Learning and Memory: Only individuals that show impaired performance on a memory test will be included in the study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Kessler Foundation — East Hanover
Идентификаторы
NCT: NCT06608797 · E-1259-24