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Набор скоро начнётся NCT07404319

Effectiveness of Exercise Alone and tDCS+Exercise on Cognitive Function Improvement in Patients With Treatment Resistant Schizophrenia

Без фазы С лечением Schizophrenia Treatment Resistant Schizophrenia Cognitive Impairment

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: Aerobic Exercise, Stretching/Education Control, Active tDCS, Sham tDCS.
Кому может быть актуально
Состояния в реестре: Schizophrenia, Treatment Resistant Schizophrenia, Cognitive Impairment. Базовые параметры: 18 лет — 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
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Официальное название

Randomised Control Trial of Effectiveness of Exercise Alone and tDCS+Exercise on Cognitive Function Improvement in Patients With Treatment Resistant Schizophrenia

Обзор

Cognitive impairment is a major determinant of disability in schizophrenia. Aerobic exercise improves global cognition in schizophrenia, particularly working memory and attention/vigilance. Transcranial direct current stimulation (tDCS) targeting frontal regions has shown promise for cognitive deficits, including working memory improvements in some studies. This randomized 2×2 factorial trial will test the independent and combined effects of supervised aerobic exercise and prefrontal tDCS on cognition in treatment resistant schizophrenia, measured using the MATRICS Consensus Cognitive Battery (MCCB).

Подробное описание

This is an individually randomized, sham controlled (tDCS), assessor blinded 2×2 factorial clinical trial comparing: (1) aerobic exercise vs stretching/education control and (2) active vs sham prefrontal tDCS. The factorial design enables estimation of the main effects of exercise and tDCS and their interaction (synergy/antagonism) in one trial.

Participants with treatment resistant schizophrenia (TRS) will complete 18 sessions over 6 weeks (3 sessions/week). Each session includes tDCS (active or sham) during the physical activity condition (aerobic exercise or stretching/education) to standardize timing and contact. Evidence suggests exercise associated cognitive gains relate to intervention dose and supervision. Noninvasive brain stimulation outcomes may vary with stimulation dose parameters, supporting a standardized protocol.

Cognition will be assessed using the MCCB, which evaluates seven cognitive domains relevant to schizophrenia and yields an Overall Composite T score. The primary endpoint is Week 6 (end of intervention), with durability assessed at 3 months post intervention (Week 18).

Вмешательства

  • Поведенческое Aerobic Exercise
    * Dose: 18 sessions over 6 weeks (3/week) * Session duration: 45-60 minutes including warm up/cool down * Intensity: Moderate (target 60-75% HRR or RPE 12-15) * Mode: Aerobic dance * Delivery: Supervised by qualified staff; HR/RPE logged each session * Rationale: Exercise improves global cognition and domains such as working memory and attention/vigilance in schizophrenia; supervision/dose relate to effect size.
  • Поведенческое Stretching/Education Control
    * Dose: 18 sessions over 6 weeks (3/week) * Session duration: 45-60 minutes * Intensity: Low (HR \<40% HRR; RPE \<10) * Components: Stretching + standardized health education modules * Purpose: Attention matched control to reduce contact/expectancy bias in non pharmacological trials.
  • Устройство Active tDCS
    * Montage: Anode F3 (left DLPFC), cathode Fp2 (right supraorbital) * Intensity: 2.0 mA * Duration: 20 minutes (30 s ramp up/down) * Schedule: 18 sessions (one per visit) * Rationale: Frontal tDCS protocols have shown promise for cognitive deficits and working memory in schizophrenia
  • Устройство Sham tDCS
    • Same montage; ramp up then off (device standard sham) to mimic cutaneous sensations.

Первичные конечные точки

  • MCCB Overall Composite T score change from baseline (Week 0) to end of intervention (Week 6). [Срок оценки: 6 weeks]
Вторичные конечные точки (4)
  • MCCB Working Memory Domain change (LNS + WMS III Spatial Span domain T score) baseline to Week 6. [Срок оценки: 6 weeks]
  • MCCB Attention/Vigilance Domain change (CPT IP domain T score) baseline to Week 6. [Срок оценки: 6 weeks]
  • Changes of negative symptoms measured with SANS from baseline to week 6 [Срок оценки: 6 weeks]
  • Durability of changes of negative symptoms relative to baseline and week 6 [Срок оценки: 18 weeks]

Критерии участия

Критерии включения

  • DSM 5 schizophrenia-spectrum disorders
  • Treatment resistant schizophrenia: inadequate response to ≥2 antipsychotics of adequate dose/duration
  • Clinically stable ≥4 weeks
  • Able to provide informed consent

Критерии исключения

  • Neurological disorder (e.g., epilepsy, stroke) or significant head injury
  • Implanted electronic devices / contraindications to tDCS; scalp lesions at electrode sites
  • Medical contraindications to moderate aerobic exercise
  • Substance dependence within 3 months (except nicotine)
  • Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

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

Идентификаторы

NCT: NCT07404319 · C7001-24Y

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗