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Bitte verwenden Sie diesen Link, wenn Sie dieses Dokument zitieren oder verlinken wollen: https://nbn-resolving.org/urn:nbn:de:gbv:9-opus-61553

Neuromodulation through brain stimulation-assisted cognitive training in patients with post-COVID-19 cognitive impairment (Neuromod-COV): study protocol for a PROBE phase IIb trial

  • Introduction A substantial number of patients diagnosed with COVID-19 experience long-term persistent symptoms. First evidence suggests that long-term symptoms develop largely independently of disease severity and include, among others, cognitive impairment. For these symptoms, there are currently no validated therapeutic approaches available. Cognitive training interventions are a promising approach to counteract cognitive impairment. Combining training with concurrent transcranial direct current stimulation (tDCS) may further increase and sustain behavioural training effects. Here, we aim to examine the effects of cognitive training alone or in combination with tDCS on cognitive performance, quality of life and mental health in patients with post-COVID-19 subjective or objective cognitive impairments. Methods and analysis This study protocol describes a prospective randomised open endpoint-blinded trial. Patients with post-COVID-19 cognitive impairment will either participate in a 3-week cognitive training or in a defined muscle relaxation training (open-label interventions). Irrespective of their primary intervention, half of the cognitive training group will additionally receive anodal tDCS, all other patients will receive sham tDCS (double-blinded, secondary intervention). The primary outcome will be improvement of working memory performance, operationalised by an n-back task, at the postintervention assessment. Secondary outcomes will include performance on trained and untrained tasks and measures of health-related quality of life at postassessment and follow-up assessments (1 month after the end of the trainings). Ethics and dissemination Ethical approval was granted by the Ethics Committee of the University Medicine Greifswald (number: BB 066/21). Results will be available through publications in peer-reviewed journals and presentations at national and international conferences. Trial registration number NCT04944147.

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Metadaten
Author: Friederike Thams, Daria Antonenko, Robert Fleischmann, Marcus Meinzer, Ulrike Grittner, Sein Schmidt, Eva-Lotta Brakemeier, Anke Steinmetz, Agnes FlöelORCiD
URN:urn:nbn:de:gbv:9-opus-61553
DOI:https://doi.org/10.1136/bmjopen-2021-055038
ISSN:2044-6055
Parent Title (English):BMJ Open
Publisher:BMJ Publishing Group
Place of publication:London
Document Type:Article
Language:English
Date of first Publication:2022/04/11
Release Date:2022/11/29
Tag:COVID-19; clinical trials; neurology
Volume:12
Article Number:e055038
Page Number:9
Faculties:Universitätsmedizin / Klinik und Poliklinik für Neurologie
Collections:Artikel aus DFG-gefördertem Publikationsfonds
Licence (German):License LogoCreative Commons - Namensnennung-Nicht kommerziell