Rocke Merle, Knochenhauer Elena, Thams Friederike, Antonenko Daria, Fromm Anna Elisabeth, Jansen Nora, Aziziaram Samaneh, Grittner Ulrike, Schmidt Sein, Vogelgesang Antje, Brakemeier Eva-Lotta, Flöel Agnes
Department of Neurology, Universitätsmedizin Greifswald, Greifswald, Germany.
Berlin Institute of Health at Charite, Berlin, Germany.
BMJ Open. 2025 May 21;15(5):e096162. doi: 10.1136/bmjopen-2024-096162.
Breast cancer is the most common form of cancer in women. A considerable number of women with breast cancer who have been treated with chemotherapy subsequently develop neurological symptoms such as concentration and memory difficulties (also known as 'chemobrain'). Currently, there are no validated therapeutic approaches available to treat these symptoms. Cognitive training holds the potential to counteract cognitive impairment. Combining cognitive training with concurrent transcranial direct current stimulation (tDCS) could enhance and maintain the effects of this training, potentially providing a new approach to treat post-chemotherapy subjective cognitive impairment (PCSCI). With this study, we aim to investigate the effects of multi-session tDCS over the left dorsolateral prefrontal cortex in combination with cognitive training on cognition and quality of life in women with PCSCI.
The Neuromod-PCSCI trial is a monocentric, randomised, double-blind, placebo-controlled study. Fifty-two women with PCSCI after breast cancer therapy will receive a 3-week tDCS-assisted cognitive training with anodal tDCS over the left dorsolateral prefrontal cortex (target intervention), compared with cognitive training plus sham tDCS (control intervention). Cognitive training will consist of a letter updating task. Primary outcome will be the performance in an untrained task (n-back task) after training. In addition, feasibility, safety and tolerability, as well as quality of life and performance in additional untrained tasks will be investigated. A follow-up visit will be performed 1 month after intervention to assess possible long-term effects. In an exploratory approach, structural and functional MRI will be acquired before the intervention and at post-intervention to identify possible neural predictors for successful intervention.
Ethical approval was granted by the ethics committee of the University Medicine Greifswald (BB236/20). Results will be available through publications in peer-reviewed journals and presentations at national and international conferences.
ClinicalTrials.gov; NCT04817566, registered on 26 March 2021.
乳腺癌是女性中最常见的癌症形式。相当数量接受化疗治疗的乳腺癌女性随后会出现神经症状，如注意力不集中和记忆困难（也称为“化疗脑”）。目前，尚无经过验证的治疗方法可用于治疗这些症状。认知训练有潜力抵消认知障碍。将认知训练与同步经颅直流电刺激（tDCS）相结合可以增强并维持这种训练的效果，有可能为治疗化疗后主观认知障碍（PCSCI）提供一种新方法。通过本研究，我们旨在探讨在左侧背外侧前额叶皮层进行多疗程tDCS结合认知训练对PCSCI女性认知和生活质量的影响。
Neuromod-PCSCI试验是一项单中心、随机、双盲、安慰剂对照研究。52名乳腺癌治疗后患有PCSCI的女性将接受为期3周的tDCS辅助认知训练，在左侧背外侧前额叶皮层进行阳极tDCS（目标干预），相比之下，另一组接受认知训练加假tDCS（对照干预）。认知训练将包括字母更新任务。主要结局将是训练后在一项未训练任务（n-back任务）中的表现。此外，还将研究可行性、安全性和耐受性，以及生活质量和在其他未训练任务中的表现。干预后1个月将进行随访，以评估可能的长期影响。以探索性方法，将在干预前和干预后进行结构和功能磁共振成像，以确定成功干预的可能神经预测因素。
已获得格赖夫斯瓦尔德大学医学伦理委员会（BB236/20）的伦理批准。结果将通过在同行评审期刊上发表以及在国内和国际会议上报告的方式公布。
ClinicalTrials.gov；NCT04817566，于2021年3月26日注册。
