Abstract
Background
Due to limitation of rehabilitation in cognitive impairment after stroke, as the main parts of traditional Chinese medicine, acupuncture and herbs have their advantage effect in clinical practice for post-stroke cognitive impairment (PSCI). Therefore, forming a standardized and propagable TCM project of PSCI becomes necessary. This trail will solve the above problem.
Methods
In total, 126 stroke patients will be recruited from the inpatient and outpatient departments of The Third Affiliated Hospital of Zhejiang Chinese Medical University (Hangzhou, China), Jiaxing Hospital of Traditional Chinese Medicine and Hangzhou Hospital of Traditional Chinese Medicine to participate in this study with randomization. All participants will continue to receive basic treatment and cognitive function regular training, while successive 12 weeks of acupuncture and herbs will be provided to patients assigned to the integrative medicine group. Montreal cognitive assessment (MOCA), mini-mental state examination, activity of daily living (ADL) score, hamilton depression scale (HAMD), functional near-infrared spectroscopy (fNIRS) and RESTing-state functional MRI (RS-fmri) will be used to measure the outcomes.
Discussion
This trial may provide high-quality RCT evidence regarding the clinical effectiveness and safety of acupuncture and herbs for PSCI patient.
Trial registration:
ClinicalTrials.gov (ID: NCT 04596072)
Reduced use of emergency care and hospitalization in patients with post-stroke cognitive impairment treated with traditional Chinese medicine
