Journal Article

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

Fromm, Anna Elisabeth, Knochenhauer, Elena, Antonenko, Daria, Thams, Friederike, Aziziaram, Samaneh, Jansen, Nora, Brakemeier, Eva-Lotta, Schmidt, Sein, Flöel, Agnes, Vogelgesang, Antje, Grittner, Ulrike, Rocke, Merle

2025

Overview

IntroductionBreast 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.Methods and analysisThe 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.Ethics and disseminationEthical 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.Trial registration numberClinicalTrials.gov; NCT04817566, registered on 26 March 2021.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Acupuncture / Adult / Antineoplastic Agents - adverse effects / Breast cancer / Breast Neoplasms - drug therapy / Cancer therapies / CHEMOTHERAPY / Chemotherapy-Related Cognitive Impairment - etiology / Chemotherapy-Related Cognitive Impairment - therapy / Cognition / Cognition & reasoning / Cognitive ability / Cognitive Behavioral Therapy - methods / Cognitive Dysfunction - chemically induced / Cognitive Dysfunction - therapy / Cognitive impairment / Cognitive Training / Dementia / Dorsolateral Prefrontal Cortex / Double-Blind Method / Exercise / Female / Humans / Intervention / Memory / Middle Aged / Mindfulness / Neurology / Performance evaluation / Prefrontal Cortex / Protocol / Quality of Life / Randomized Controlled Trials as Topic / Substance abuse treatment / Transcranial Direct Current Stimulation - methods