JMIR Publications

ABSTRACT

Background:

Vascular cognitive impairment (VCI) persistently impairs cognition and the ability to perform activities of daily living, seriously compromising patients’ quality of life. Previous studies have reported that disorders of serum iron metabolism and iron deposition in the brain can lead to inflammation, abnormal protein aggregation and degeneration, and massive neuronal apoptosis in the central nervous system, which in turn leads to a progressive decline in cognitive processes. Our previous clinical studies have found acupuncture to be a safe and effective intervention for treating VCI, but the specific mechanisms require further exploration.

Objective:

Here we propose a randomized controlled trial to evaluate the clinical efficacy of Tongdu Xingshen acupuncture, and to investigate whether it can improve VCI by regulating brain iron deposition and body iron metabolism.

Methods:

A total of 42 patients with VCI will be recruited and divided into an acupuncture group and a control group according to our inclusion criteria, and 21 healthy individuals will be enrolled in a healthy control group. Both the control group and the acupuncture group will receive conventional internal medicine and cognitive rehabilitation training, and the acupuncture group will also receive Tongdu Xingshen electroacupuncture treatment for 30 minutes per session, six times per week, over a 4-week period. Meanwhile, the healthy control group will not receive any intervention. All three groups will undergo baseline assessments of brain iron deposition, serum iron metabolism and neuropsychological tests after enrollment. The acupuncture and control groups will be evaluated again at the end of 4 weeks of treatment, as described above. By comparing neuropsychological test scores between groups, we will examine the efficacy of “Tongdu Xingshen” acupuncture in treating VCI. Additionally, we will test the correlations between neuropsychological test scores, brain iron deposition, and body iron metabolism indexes, to explore the possible mechanisms of Tongdu Xingshen acupuncture in treating VCI.

Results:

Participants are currently being recruited. The first participant was enrolled in June 2023, which marked the official start of the experiment. And as of the submission of the manuscript, there were 23 participants.The recruitment process is expected to continue until June 2025, at which point the processing and analysis of data will begin.

Conclusions:

This study will provide data on the effects of “Tongdu Xingshen” acupuncture on cerebral iron deposition as well as somatic iron metabolism in patients with VCI, which will provide clinical and theoretical basis for the wide application of acupuncture therapy in VCI rehabilitation. Clinical Trial: Chinese Clinical Trial Registry NO. ChiCTR2300072188. Registered on 6 June 2023.