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Идёт набор NCT07747181

The Effect of Combined Brain Stimulation and Yoga for Improving Cognitive Function in Psychosis

Без фазы С лечением Cognitive Functioning Psychosis

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: Active tDCS, Sham tDCS, Yoga.
Кому может быть актуально
Состояния в реестре: Cognitive Functioning, Psychosis. Базовые параметры: 18 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Yoga and tDCS to Improve Cognitive Function in Individuals With Psychosis: A Pragmatic Controlled Trial

Обзор

The study examines (1) the effects of active anodal (facilitatory) tDCS and yoga combined intervention on cognitive function, clinical symptoms, and quality of life domains (social function and physical wellbeing) in psychosis, and (2) the neurophysiological mechanisms underlying the effects induced by the combined intervention.

Вмешательства

  • Устройство Active tDCS
    Active tDCS will be applied using a wearable stimulator (LifTid) with a constant stimulation intensity of 1.2 mA for 20 minutes. The device has been designed for anodal stimulation targeting DLPFC using the F3 (anode) to F4 (cathode) montage.
  • Устройство Sham tDCS
    Sham tDCS will be performed using the same device but without stimulation. During the yoga training, all participants will wear the device and a facilitator will turn on the stimulation for participants receiving a-tDCS-Y intervention, and pretend to turn on the stimulation for participants receiving s-tDCS-Y intervention after the first 10-minute section.
  • Поведенческое Yoga
    Yoga will be based on the basic theory and research of the foundation of Hatha yoga. Participants will cultivate the learning of yoga through various kinds of activity, such as breathing control, body postures, and relaxation. The yoga is designed to create an overall effect on the body and mind through strength training and stretching with a mindful sensation. Each 1-hour intervention session contains reviewing the last week self-practice, breathing practice and warm-up (10 minutes), posture se

Первичные конечные точки

  • Verbal Fluency Test [Срок оценки: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
Вторичные конечные точки (12)
  • Logical Memory test [Срок оценки: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Digit Span Test [Срок оценки: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Positive and Negative Syndrome Scale (PANSS) [Срок оценки: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Calgary Depression Scale [Срок оценки: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Social and Occupational Functioning Assessment Scale (SOFAS) [Срок оценки: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Role Functioning Scale (RFS) [Срок оценки: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • The Short Form Health Survey (SF-36) [Срок оценки: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • BMI [Срок оценки: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Sit-and-Reach Test [Срок оценки: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Standing Balance Test [Срок оценки: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Digit Symbol Coding Test [Срок оценки: Baseline (T0), after the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]
  • Letter Cancellation Test [Срок оценки: After the 6-week interventions/waiting (T1), and at the 3-month follow-up (T2)]

Критерии участия

Критерии включения

  • (1) aged 18 to 65 years
  • (2) diagnosis based on SCID for schizophrenia and related disorders, psychosis, and delusional disorder with the positive symptom measured by CGI ≤ 3
  • (3) ability to understand the nature of the study and to give informed consent (The MacArthur Competence Assessment Tool for Clinical Research score ≥ 35)
  • (4) Chinese-speaking
  • (5) fewer than 10 hours of yoga and other mind-body intervention (e.g., Tai Chi, Qigong, Mindfulness) in the previous 3 months.

Критерии исключения

  • (1) Severe physical diseases, such as myocardial infarction, uncontrollable severe hypertension, fracture, severe spinal problems, or contraindication for exercise
  • (2) comorbid substance dependence and seizure disorders
  • (3) pregnancy or other contraindication to fNIRS
  • (4) known history of intellectual disability or special school attendance, brain trauma, or organic brain disease
  • (5) Individuals taking Benzodiazepine will still be recruited in the project, and will be excluded from the fNIRS measure.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

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

Идентификаторы

NCT: NCT07747181 · 25124024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗