Transcutaneous auricular vagus nerve stimulation in poststroke cognitive impairment: protocol for a randomised controlled trial

BackgroundAs one of the most common stroke sequelae, poststroke cognitive impairment significantly impacts 17.6%–83% of survivors, affecting their rehabilitation, daily living and quality of life. Improving cognitive abilities among patients in stroke recovery is therefore critical and urgent. Trans...

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Bibliographic Details
Published in:BMJ open 2022-10, Vol.12 (10), p.e063803-e063803
Main Authors: Li, Zhen-Dong, Qiu, Hang-Jian, Wang, Xiao-Qian, Zhang, Cheng-Cheng, Zhang, Yue-Juan
Format: Article
Language:English
Subjects:
Activities of daily living
Alzheimer's disease
Clinical trials
Cognitive ability
delirium & cognitive disorders
Dementia
FDA approval
Hospitals
Informed consent
Intervention
Ischemia
Memory
Neuropsychology
Oxidative stress
Patients
Quality of life
Rehabilitation Medicine
Stroke
Substance abuse treatment
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Summary:BackgroundAs one of the most common stroke sequelae, poststroke cognitive impairment significantly impacts 17.6%–83% of survivors, affecting their rehabilitation, daily living and quality of life. Improving cognitive abilities among patients in stroke recovery is therefore critical and urgent. Transcutaneous auricular vagus nerve stimulation (TAVNS) is a non-invasive, safe, cost-effective treatment with great potential for improving the cognitive function of poststroke patients. This clinical research will evaluate the effectiveness, and help elucidate the possible underlying mechanisms, of TAVNS for improving poststroke cognitive function.Methods and analysisA single-centre, parallel-group, allocation concealment, assessor-blinded randomised controlled clinical trial. We will allocate 88 recruited participants to the TAVNS or sham group for an intervention that will run for 8 weeks, 5 days per week with twice daily sessions lasting 30 min each. Blood tests will be performed and questionnaires issued at baseline and 8-week and 12 week follow-ups. Primary outcomes will be changes in cognitive function scores. Secondary outcomes will be changes in activities of daily living, quality of life and serum oxidative stress indicators.Ethics and disseminationThe Ethics Committee of the First Affiliated Hospital of Hunan University of Chinese Medicine has approved the protocol (No. HN-LL-YJSLW-2022200). Findings will be published in peer-reviewed academic journals and presented at scientific conferences.Trial registration numberChiCTR2200057808.
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2022-063803