Integrative medicine in treating post-stroke depression: Study protocol for a multicenter, prospective, randomized, controlled trial

Jing Chen, Ke Shen, Lijuan Fan, Hantong Hu, Tieniu Li, Yiting Zhang, Hong Gao, Jing Chen, Ke Shen, Lijuan Fan, Hantong Hu, Tieniu Li, Yiting Zhang, Hong Gao

Abstract

Background: Post-stroke depression (PSD) is one of the most common neuropsychiatric diseases in patients with stroke, and it can increase the disability rate, mortality, and recurrence rate of stroke. Currently, many clinical studies have indicated that traditional Chinese medicine (TCM), such as acupuncture and herbs, Western medicine, rehabilitation, repeated transcranial magnetic stimulation, and other treatment methods, are effective in treating PSD. However, no study has formulated a comprehensive treatment plan that integrates TCM, Western medicine, and rehabilitation for PSD. Thus, this trial aims to assess the efficacy and safety of integrative medicine for treating PSD.

Methods: This multicenter, prospective, randomized, controlled study aims to form a set of effective clinical treatment schemes that integrate TCM, Western medicine, and rehabilitation for PSD. A total of 202 participants recruited from four centers will be randomized into either the integrative medicine or standard care group. Standard care-basic treatment, general nursing care, and exercise therapy-will be provided to all participants. The integrative medicine group will also receive acupuncture, Chinese herbs, and repeated transcranial magnetic stimulation (rTMS). Participants will receive acupuncture and rTMS treatments five times per week for 4 weeks and will be administered Chinese herbs, basic treatment, general nursing care, and exercise therapy for 4 weeks. The primary outcomes include the Hamilton Depression Scale (HAMD), Self-Rating Depression Scale (SDS), and Activity of Daily Living Scale (ADL). And the secondary outcomes include the Montreal Cognitive Assessment Scale, the Fugl-Meyer Assessment (FMA) Scale, and the Pittsburgh Sleep Quality Index (PSQI). All outcome measures will be evaluated at baseline, week 4 (the end of the treatment courses), and week 8 (the end of follow-up). Safety assessments will be performed throughout the study.

Discussion: This study is expected to verify the efficacy and safety of integrative medicine for treating PSD, providing an evidence-based clinical reference for the future development of a standardized scheme.

Clinical trial registration: ClinicalTrials.gov, identifier: NCT05187975.

Keywords: acupuncture; integrative medicine; post-stroke depression; repeated transcranial magnetic stimulation; traditional Chinese medicine.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Chen, Shen, Fan, Hu, Li, Zhang and Gao.

Figures

Figure 1
Figure 1
Flowchart of the trial. rTMS, Repeated Transcranial Magnetic Stimulation; HAMD, Hamilton Depression Scale; SDS Self-Rating Depression Scale; ADL, Activities of Daily Living; MoCA, Montreal Cognitive Assessment scale; FMA, the Fugl-Meyer Assessment of Motor Function Scale.

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