- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04955275
The Efficacy of a Remote Cognitive Remediation Therapy (CRT) Program on Parkinson's Disease
Purpose/Goal: To determine if a remote computerized cognitive remediation program (CRT) can stabilize or improve cognitive functioning in a group of patients from the New York Institute of Technology Academic Health Care Center with Parkinson's disease (PD) after three months of intervention.
Hypothesis: Patients with PD who present with current cognitive deficits will show improvement in such deficits after three months of participation in a remotely supervised structured Cognitive Remediation Therapy Program (CRT) compared to control subjects with PD who receive treatment as usual.
Research design: Pilot study. Prospective randomized treatment and control comparison pre-post study.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
New York
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Old Westbury, New York, Соединенные Штаты, 11568
- New York Institute of Technology
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Subjects must be currently enrolled in the Rock Steady Boxing Program at the Adele Smithers Parkinson's Disease Center.
- Subjects must be between 40 and 85 years old (including both ages) at the time of study screening.
- Subjects must have a diagnosis of Parkinson's disease by a physician.
- Subjects must have a MOCA score of 20 or above.
- Subjects must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
- Subjects must have been clinically stable for 2 weeks prior to consent; in the judgment of the Investigator.
- Subjects must have the visual, auditory, and motor capacity to use the intervention in the judgment of the Principal Investigator.
- Subjects must be technologically capable of utilizing a computer and navigating through the programs.
- Subjects must be mechanically capable of utilizing a computer and computer mouse.
Exclusion Criteria:
- Subjects should not be participating in a concurrent research study or other interventional clinical trial 30 days prior to consenting.
- Subjects should not have a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.)
- Subject is unable to physically use a computer or a computer mouse.
- Subject is unable to or refuses to give consent.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Parkinson's Disease Patients receiving Cognitive Remediation Therapy
Parkinson's Disease Subjects will undergo 10 weeks of Brain HQ training, 2 times a week an hour at a time.
Also patients pre- and post-intervention RBANS and PDQ-39 scores.
|
Brain HQ games involving training cognitive abilities like memory and attention, made up of adapting tasks or creating our own.
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Без вмешательства: Parkinson's Disease Patients not receiving Cognitive Remediation Therapy
Parkinson's Disease Subjects will receive no intervention, but still undergo pre- and post-intervention RBANS and PDQ-39 scores.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Pre-Intervention
Временное ограничение: Initially, before any intervention/start of study.
|
A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory.
|
Initially, before any intervention/start of study.
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The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Post-Intervention
Временное ограничение: 10 weeks after intervention/completion of the study.
|
A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory.
|
10 weeks after intervention/completion of the study.
|
Parkinson's Disease Questionnaire (PDQ-39) Pre-Intervention
Временное ограничение: Initially, before any intervention/start of study.
|
A test that assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication.
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Initially, before any intervention/start of study.
|
Parkinson's Disease Questionnaire (PDQ-39) Post-Intervention
Временное ограничение: 10 weeks after intervention/completion of the study.
|
A test that assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication.
|
10 weeks after intervention/completion of the study.
|
Montreal Cognitive Assessment (MOCA) Pre-Intervention Screening
Временное ограничение: Initially, before any intervention/start of study.
|
A rapid screening instrument for mild cognitive dysfunction.
It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
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Initially, before any intervention/start of study.
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Milman U, Atias H, Weiss A, Mirelman A, Hausdorff JM. Can cognitive remediation improve mobility in patients with Parkinson's disease? Findings from a 12 week pilot study. J Parkinsons Dis. 2014;4(1):37-44. doi: 10.3233/JPD-130321.
- Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: a concept in evolution. J Intern Med. 2014 Mar;275(3):214-28. doi: 10.1111/joim.12190.
- Diez-Cirarda M, Ibarretxe-Bilbao N, Pena J, Ojeda N. Efficacy of cognitive rehabilitation in Parkinson's disease. Neural Regen Res. 2018 Feb;13(2):226-227. doi: 10.4103/1673-5374.226390. No abstract available.
- Diez-Cirarda M, Ojeda N, Pena J, Cabrera-Zubizarreta A, Lucas-Jimenez O, Gomez-Esteban JC, Gomez-Beldarrain MA, Ibarretxe-Bilbao N. Increased brain connectivity and activation after cognitive rehabilitation in Parkinson's disease: a randomized controlled trial. Brain Imaging Behav. 2017 Dec;11(6):1640-1651. doi: 10.1007/s11682-016-9639-x.
- Gough N, Brkan L, Subramaniam P, Chiuccariello L, De Petrillo A, Mulsant BH, Bowie CR, Rajji TK. Feasibility of remotely supervised transcranial direct current stimulation and cognitive remediation: A systematic review. PLoS One. 2020 Feb 24;15(2):e0223029. doi: 10.1371/journal.pone.0223029. eCollection 2020.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- BHS-1660
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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