Journal Article

DZNE-2025-00632

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png 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.

Rocke, M. ; Knochenhauer, E. ; Thams, F. ; Antonenko, D. ; Fromm, A. E. ; Jansen, N. ; Aziziaram, S. ; Grittner, U. ; Schmidt, S. ; Vogelgesang, A. ; Brakemeier, E.-L. ; Flöel, A. (Last author)DZNE*

2025
BMJ Publishing Group London

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Please use a persistent id in citations: doi:10.1136/bmjopen-2024-096162

Abstract: 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.

Keyword(s): Humans (MeSH) ; Breast Neoplasms: drug therapy (MeSH) ; Female (MeSH) ; Transcranial Direct Current Stimulation: methods (MeSH) ; Double-Blind Method (MeSH) ; Quality of Life (MeSH) ; Randomized Controlled Trials as Topic (MeSH) ; Cognitive Behavioral Therapy: methods (MeSH) ; Chemotherapy-Related Cognitive Impairment: therapy (MeSH) ; Chemotherapy-Related Cognitive Impairment: etiology (MeSH) ; Cognitive Dysfunction: therapy (MeSH) ; Cognitive Dysfunction: chemically induced (MeSH) ; Middle Aged (MeSH) ; Adult (MeSH) ; Dorsolateral Prefrontal Cortex (MeSH) ; Prefrontal Cortex (MeSH) ; Cognition (MeSH) ; Antineoplastic Agents: adverse effects (MeSH) ; Cognitive Training (MeSH) ; CHEMOTHERAPY ; Cognition ; Quality of Life ; Antineoplastic Agents

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Contributing Institute(s):

1. Dementia Prevention – Mechanisms and Clinical Implementation (AG Flöel)

Research Program(s):

1. 353 - Clinical and Health Care Research (POF4-353) (POF4-353)

Appears in the scientific report 2025

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Database coverage:
; ; ; ; Article Processing Charges ; Clarivate Analytics Master Journal List ; DOAJ Seal ; Essential Science Indicators ; Fees ; IF < 5 ; JCR ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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