Neuromodulation Through Brain Stimulation-assisted Cognitive Training in Patients With Post-chemotherapy Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Working memory performance at post-assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chemotherapy to treat breast cancer (≥ 6 months post-treatment).
- •Self-reported concerns regarding cognitive functioning.
- •Age: 18-65 years.
- •right-handedness
排除标准
- •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)
结局指标
主要结局
Working memory performance at post-assessment
时间窗: 3 weeks
Performance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task
次要结局
- Working memory training performance (Letter Updating Task) at follow-up assessment(4 weeks after training)
- Quality of Life at post-assessment(3 weeks)
- Visuo-spatial performance at follow-up assessment(3 weeks)
- Working memory performance at follow-up assessment(4 weeks after training)
- Working memory training performance (Letter Updating Task) at post-assessment(3 weeks)
- Quality of Life at follow-up assessment(4 weeks after training)
- Visuo-spatial performance at post-assessment(3 weeks)