TY  - JOUR
AU  - Rocke, Merle
AU  - Knochenhauer, Elena
AU  - Thams, Friederike
AU  - Antonenko, Daria
AU  - Fromm, Anna Elisabeth
AU  - Jansen, Nora
AU  - Aziziaram, Samaneh
AU  - Grittner, Ulrike
AU  - Schmidt, Sein
AU  - Vogelgesang, Antje
AU  - Brakemeier, Eva-Lotta
AU  - Flöel, Agnes
TI  - 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.
JO  - BMJ open
VL  - 15
IS  - 5
SN  - 2044-6055
CY  - London
PB  - BMJ Publishing Group
M1  - DZNE-2025-00632
SP  - e096162
PY  - 2025
AB  - 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.
KW  - Humans
KW  - Breast Neoplasms: drug therapy
KW  - Female
KW  - Transcranial Direct Current Stimulation: methods
KW  - Double-Blind Method
KW  - Quality of Life
KW  - Randomized Controlled Trials as Topic
KW  - Cognitive Behavioral Therapy: methods
KW  - Chemotherapy-Related Cognitive Impairment: therapy
KW  - Chemotherapy-Related Cognitive Impairment: etiology
KW  - Cognitive Dysfunction: therapy
KW  - Cognitive Dysfunction: chemically induced
KW  - Middle Aged
KW  - Adult
KW  - Dorsolateral Prefrontal Cortex
KW  - Prefrontal Cortex
KW  - Cognition
KW  - Antineoplastic Agents: adverse effects
KW  - Cognitive Training
KW  - CHEMOTHERAPY (Other)
KW  - Cognition (Other)
KW  - Quality of Life (Other)
KW  - Antineoplastic Agents (NLM Chemicals)
LB  - PUB:(DE-HGF)16
C6  - pmid:40398955
DO  - DOI:10.1136/bmjopen-2024-096162
UR  - https://pub.dzne.de/record/278796
ER  -