Cognitive Training and Brain Stimulation in Women With Post-chemotherapy 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: Anodal tDCS, Sham tDCS, Intensive cognitive training.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer, Cognitive Impairment. Базовые параметры: 18 лет — 65 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Германия
- 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
Neuromodulation Through Brain Stimulation-assisted Cognitive Training in Patients With Post-chemotherapy Cognitive Impairment
Обзор
The aim of this study is to investigate whether a high definition tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in women with post-chemotherapy cognitive impairment after breast cancer treatment.
Подробное описание
Patients who have undergone chemotherapy, may develop post-chemotherapy cognitive impairment (PCCI), which may occur in several cognitive domains and persist for many years. These declines in cognitive functions can lead to psychological distress and affect overall patients' quality of life. The goal of the present study is to assess behavioral effects of a multi-session cognitive training combined with high-definition transcranial direct current stimulation (tDCS) in women with PCCI. First studies have shown positive effects of cognitive training on trained and untrained functions and the subjective perception of stress, however the effects are small and transfer effects are inconsistent. A promising approach to elongate and increase the effects of cognitive training is to combine the training with tDCS. Therefore, in this study women with PCCI will participate in a three-week cognitive training with concurrent online high-definition tDCS application. Cognitive performance (primary), as well as Quality of Life scores and Sleep data will be examined before, during and after the intervention. In order to draw conclusions about the effect of tDCS in addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. A Follow-up session to assess long-term effects is planned four weeks after the post assessment. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training intervention in women with PCCI in order to establish its potential to induce improvements in cognitive functions, and to beneficially affect patient-reported outcome measures.
Вмешательства
- Устройство Anodal tDCS
Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA). - Устройство Sham tDCS
Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants. - Поведенческое Intensive cognitive training
Intensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min
Первичные конечные точки
- Working memory performance at post-assessment [Срок оценки: 3 weeks]
Вторичные конечные точки (7)
- Working memory performance at follow-up assessment [Срок оценки: 4 weeks after training]
- Working memory training performance (Letter Updating Task) at post-assessment [Срок оценки: 3 weeks]
- Working memory training performance (Letter Updating Task) at follow-up assessment [Срок оценки: 4 weeks after training]
- Quality of Life at post-assessment [Срок оценки: 3 weeks]
- Quality of Life at follow-up assessment [Срок оценки: 4 weeks after training]
- Visuo-spatial performance at post-assessment [Срок оценки: 3 weeks]
- Visuo-spatial performance at follow-up assessment [Срок оценки: 3 weeks]
Критерии участия
Критерии включения
- Chemotherapy to treat breast cancer (≥ 6 months post-treatment).
- Self-reported concerns regarding cognitive functioning.
- Age: 18-65 years.
- right-handedness
Критерии исключения
- History of dementia before treatment of cancer.
- Other neurodegenerative neurological disorders; epilepsy or history of seizures.
- Severe and untreated medical conditions that preclude participation in the training, as determined by responsible physician.
- History of moderate to severe substance use disorder according to DSM-5
- Moderate to severe acute psychiatric disorders according to DSM-5
- Contraindication to tDCS application (Antal et al., 2017)
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
Германия · 1 центр
- University Medicine Greifswald — Greifswald
Публикации
- Rocke M, Knochenhauer E, Thams F, Antonenko D, Fromm AE, Jansen N, Aziziaram S, Grittner U, Schmidt S, Vogelgesang A, Brakemeier EL, Floel A. Neuromodulation through brain stimulation-assisted cognitive training in patients with post-chemotherapy subjective cognitive impairment (Neuromod-PCSCI) after breast cancer: study protocol for a double-blinded randomised controlled trial. BMJ Open. 2025 May PMID 40398955
Идентификаторы
NCT: NCT04817566 · NeuroMod-PCCI