Меню
Набор скоро начнётся NCT06838494

Using Immersive Virtual Reality for Cognitive Therapy in Elderly with Mild Cognitive Impairment

Без фазы С лечением Mild Cognitive Impairment (MCI)

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: IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy), Intervention Name: Conventional CST (Cognitive Stimulation Therapy).
Кому может быть актуально
Состояния в реестре: Mild Cognitive Impairment (MCI). Базовые параметры: от 60 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Utilization of Immersive Virtual Reality in Cognitive Stimulation Therapy (IVR-CST) for Elderly with Mild Cognitive Impairment: a Randomized Controlled Pilot Study

Обзор

The proposed study aims to investigate the potential of IVR-CST in improving cognition of people with MCI, and as well the association of eye movement during therapy and treatment outcomes of IVR-CST. Four research questions have been proposed and listed as follows: 1. Is IVR-CST a feasible treatment for elderly with MCI? 2. Is IVR-CST an efficacious treatment for improving cognition of elderly with MCI? 3. Is IVR-CST more efficacious than conventional CST (i.e., without IVR) in improving the cognition of elderly with MCI? 4. Is eye-tracking data collected during therapy associated with treatment outcomes of IVR CST?

Вмешательства

  • Поведенческое IVR-CST (Immersive Virtual Reality Cognitive Stimulation Therapy)
    IVR-CST involves 14 sessions of cognitive stimulation therapy conducted twice a week in a virtual reality environment. Each session lasts approximately 45 minutes and utilizes head-mounted displays (HMDs) to immerse participants in engaging, themed activities. The therapy aims to enhance cognitive function and social interaction through interactive and stimulating virtual experiences tailored for individuals with mild cognitive impairment (MCI).
  • Поведенческое Intervention Name: Conventional CST (Cognitive Stimulation Therapy)
    Conventional CST consists of 14 sessions of cognitive stimulation therapy conducted twice a week, each lasting about 45 minutes. In this arm, participants engage in group activities using physical materials, such as photos, pictures, and real objects, rather than virtual reality. The therapy focuses on providing cognitive stimulation through discussions and activities designed to improve cognitive function and social engagement among individuals with mild cognitive impairment (MCI).

Первичные конечные точки

  • Hong Kong Montreal Cognitive Assessment (HK-MoCA) [Срок оценки: From 1-week pre-intervention to 13 weeks post-intervention]
  • Digit Span Forward and Backward Tasks [Срок оценки: From 1-week pre-intervention to 13 weeks post-intervention]
  • Verbal Fluency of Semantic Category [Срок оценки: From 1-week pre-intervention to 13 weeks post-intervention]
Вторичные конечные точки (4)
  • Chinese Version of the Modified Barthel Index [Срок оценки: From 1-week pre-intervention to 13 weeks post-intervention]
  • Hong Kong Lawton Instrumental Activities of Daily Living Scale [Срок оценки: From 1-week pre-intervention to 13 weeks post-intervention]
  • Feasibility Outcomes and Users' Experience [Срок оценки: Throughout the intervention period (from weeks 1-7 of intervention)]
  • Semi-Structured Interview for IVR-CST Group [Срок оценки: Immediately post-intervention]

Критерии участия

Критерии включения

  • elderly aged 60 years or above,
  • a diagnosis of MCI made by a psychiatrist, or a score of 16-21 out of 30 in the Hong Kong Brief Cognitive Test (HKBC, 31), with upper and lower cutoff scores for MCI as suggested by the test. HKBC has been validated in Hong Kong with satisfactory sensitivity (0.88) and specificity ((0.81) in differentiating subjects with MCI and healthy individuals,
  • ability to speak and comprehend Cantonese,
  • normal or corrected-to-normal binocular vision and hearing,
  • absence of physical illness/disability to prevent them from IVR-CST participation, 6, compatible with IVR exposure in the 10-minute IVR trial without major signs of cybersickness, based on the symptoms given in the Simulator Sickness Questionnaire

Критерии исключения

  • concurrent participation in other clinical therapy trials,
  • incompatibility with IVR exposure such as complaints of nausea, headache, or other severe discomforts during trial use,
  • a diagnosis of dementia or other psychiatric/neurological diseases such as depression, stroke, brain trauma, Parkinson's disease
  • hearing/visual/upper limb impairments that hinder CST/IVR-CST participation,
  • prior CST treatment,
  • Use of medication for MCI/dementia, e.g., aducanumab

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
Простое слепое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • The Hong Kong Polytechnic University — Гонконг

Публикации

  • Wong WWS, Wong GHY, Choy JCP, Pui Li DS, Lo YL. Utilization of Immersive Virtual Reality in Cognitive Stimulation Therapy (IVR-CST) for elderly with mild cognitive impairment: A randomized controlled pilot study protocol. PLoS One. 2025 Aug 26;20(8):e0330686. doi: 10.1371/journal.pone.0330686. eCollection 2025. PMID 40857307

Идентификаторы

NCT: NCT06838494 · HSEARS20241010009 · 22231471

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗