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

doi:10.1136/bmjopen-2024-096162

Items
Marc 21

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024	7	_	\|a 10.1136/bmjopen-2024-096162 \|2 doi
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041	_	_	\|a English
082	_	_	\|a 610
100	1	_	\|a Rocke, Merle \|b 0
245	_	_	\|a 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.
260	_	_	\|a London \|c 2025 \|b BMJ Publishing Group
336	7	_	\|a article \|2 DRIVER
336	7	_	\|a Output Types/Journal article \|2 DataCite
336	7	_	\|a Journal Article \|b journal \|m journal \|0 PUB:(DE-HGF)16 \|s 1748946707_16670 \|2 PUB:(DE-HGF)
336	7	_	\|a ARTICLE \|2 BibTeX
336	7	_	\|a JOURNAL_ARTICLE \|2 ORCID
336	7	_	\|a Journal Article \|0 0 \|2 EndNote
520	_	_	\|a 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.
536	_	_	\|a 353 - Clinical and Health Care Research (POF4-353) \|0 G:(DE-HGF)POF4-353 \|c POF4-353 \|f POF IV \|x 0
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650	_	7	\|a CHEMOTHERAPY \|2 Other
650	_	7	\|a Cognition \|2 Other
650	_	7	\|a Quality of Life \|2 Other
650	_	7	\|a Antineoplastic Agents \|2 NLM Chemicals
650	_	2	\|a Humans \|2 MeSH
650	_	2	\|a Breast Neoplasms: drug therapy \|2 MeSH
650	_	2	\|a Female \|2 MeSH
650	_	2	\|a Transcranial Direct Current Stimulation: methods \|2 MeSH
650	_	2	\|a Double-Blind Method \|2 MeSH
650	_	2	\|a Quality of Life \|2 MeSH
650	_	2	\|a Randomized Controlled Trials as Topic \|2 MeSH
650	_	2	\|a Cognitive Behavioral Therapy: methods \|2 MeSH
650	_	2	\|a Chemotherapy-Related Cognitive Impairment: therapy \|2 MeSH
650	_	2	\|a Chemotherapy-Related Cognitive Impairment: etiology \|2 MeSH
650	_	2	\|a Cognitive Dysfunction: therapy \|2 MeSH
650	_	2	\|a Cognitive Dysfunction: chemically induced \|2 MeSH
650	_	2	\|a Middle Aged \|2 MeSH
650	_	2	\|a Adult \|2 MeSH
650	_	2	\|a Dorsolateral Prefrontal Cortex \|2 MeSH
650	_	2	\|a Prefrontal Cortex \|2 MeSH
650	_	2	\|a Cognition \|2 MeSH
650	_	2	\|a Antineoplastic Agents: adverse effects \|2 MeSH
650	_	2	\|a Cognitive Training \|2 MeSH
700	1	_	\|a Knochenhauer, Elena \|b 1
700	1	_	\|a Thams, Friederike \|b 2
700	1	_	\|a Antonenko, Daria \|b 3
700	1	_	\|a Fromm, Anna Elisabeth \|0 0000-0001-7709-3311 \|b 4
700	1	_	\|a Jansen, Nora \|b 5
700	1	_	\|a Aziziaram, Samaneh \|b 6
700	1	_	\|a Grittner, Ulrike \|b 7
700	1	_	\|a Schmidt, Sein \|b 8
700	1	_	\|a Vogelgesang, Antje \|b 9
700	1	_	\|a Brakemeier, Eva-Lotta \|b 10
700	1	_	\|a Flöel, Agnes \|0 P:(DE-2719)2812683 \|b 11 \|e Last author
773	_	_	\|a 10.1136/bmjopen-2024-096162 \|g Vol. 15, no. 5, p. e096162 - \|0 PERI:(DE-600)2599832-8 \|n 5 \|p e096162 \|t BMJ open \|v 15 \|y 2025 \|x 2044-6055
856	4	_	\|y OpenAccess \|u https://pub.dzne.de/record/278796/files/DZNE-2025-00632.pdf
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Marc 21

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