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Идёт набор NCT05830942

Up-2 Study: Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults

Без фазы С лечением Cognitive Dysfunction Mobility Limitation Frail Elderly

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: Walking Exercise, Prefrontal Active tDCS, Prefrontal Sham tDCS.
Кому может быть актуально
Состояния в реестре: Cognitive Dysfunction, Mobility Limitation, Frail Elderly. Базовые параметры: от 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
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Официальное название

Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults

Обзор

Declines in cognitive function and walking function are highly intertwined in older adults. A therapeutic approach that combines complex (cognitively engaging) aerobic walking exercise with non-invasive electrical brain stimulation may be effective at restoring lost function. This study tests whether electrical stimulation of prefrontal brain regions is more beneficial than sham stimulation.

Подробное описание

Efficacy of transcranial direct current stimulation (tDCS) combined with complex (cognitively engaging) walking exercise in older adults. The primary outcome measures are executive function (computer-based assessment battery) and complex walking function (speed on an obstacle negotiation task). This will be a two-site trial conducted at the University of Florida (lead site) and Brooks Rehabilitation Hospital, which is necessary to achieve enrollment targets and will allow us to develop a multi-site research infrastructure for a future Phase 3 multi-site trial. The study will enroll up to 120 older adult women and men, who exhibit mild to moderate decline of executive function. All experimental groups will receive the same complex walking intervention, which will focus on use of cognitively engaging tasks such as obstacle crossing, accurate foot placement, and walking on complaint surfaces. Each session will consist of 30 minutes of walking. For tDCS, the active treatment group will receive 20 minutes of 2mA tDCS over prefrontal regions F3/F4 ("treatment group"). The second group is a sham control group. tDCS will be delivered simultaneously with complex walking exercise for 18 sessions over a 6-week period. Assessments will be conducted at baseline, post intervention (within one week), and 12 weeks post-intervention.

Вмешательства

  • Поведенческое Walking Exercise
    aerobic walking exercise using complex (cognitively engaging) walking tasks
  • Устройство Prefrontal Active tDCS
    20 minutes of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session
  • Устройство Prefrontal Sham tDCS
    30 seconds of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session

Первичные конечные точки

  • walking speed for obstacle task negotiation task [Срок оценки: baseline, post-intervention (an average of 6 weeks after baseline), follow-up (an average of 12 weeks after post-intervention)]
  • score on test of executive function [Срок оценки: baseline, post-intervention (an average of 6 weeks after baseline), follow-up (an average of 12 weeks after post-intervention)]

Критерии участия

Критерии включения

  • Age 65+
  • Objective executive function decline, based on standardized cognitive assessments.
  • Subjective cognitive decline, based on the question: "During the past 12 months, have you experienced confusion or memory loss that is happening more often or getting worse?"
  • Ability to walking independently for 6 minutes (use of cane permitted)

Критерии исключения

  • Major cognitive disorder that interferes with independence
  • Percentile score less than 10th percentile on standardized cognitive assessments
  • Medications that are thought to influence tDCS neuroplasticity.
  • Contraindications to tDCS or MRI.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • University of Florida — Gainesville
  • Brooks Rehabilitation — Jacksonville

Идентификаторы

NCT: NCT05830942 · IRB202300001 · PRO00046897 · R01AG081477 · 1R01AG081477-01 · IRB202300002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗