Based on voxel-based morphological analysis to investigate the effect of acupuncture-rehabilitation therapy on hippocampal volume and its neuroprotective mechanism in patients with vascular cognitive impairment with type 2 diabetes mellitus: A study protocol

BACKGROUND: Vascular cognitive impairment (VCI) has a decline in the ability of learning, memory, understanding and execution, which seriously interferes with the daily life of patients. Type 2 diabetes mellitus (T2DM) is an important risk factor for VCI. In recent years, the pathogenesis and treatment of VCI with T2DM have become a research hotspot. Acupuncture-rehabilitation therapy plays an important role in the treatment of various functional disorders of cerebrovascular diseases. In the previous study of the research group, it has been proved from the perspective of imaging that acupuncture-rehabilitation therapy can improve the cognitive function of patients with ischemic stroke. Based on the previous research results, we speculate that acupuncture-rehabilitation therapy not only improves the function of cognitive-related brain regions, but also affects its structure, as well as serum biomarkers highly related to T2DM and cognitive function. METHODS/DESIGN: A partial randomized controlled trial will be conducted at the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, between July 1, 2021 and December 31, 2023. A total of 80 subjects will participate in the trial, including 25 healthy volunteers, 25 T2DM patients with normal cognitive function and 30 VCI patients with T2DM. They will all have at least 1 functional magnetic resonance imaging scan. Through the calculation and analysis of voxel-based morphological analysis indexes, the changes of hippocampal volume and function in the 3 groups are compared, so as to confirm the correlation between hippocampal structural and functional changes, between T2DM patients and healthy volunteers, as well as T2DM patients with normal cognitive and VCI patients with T2DM. Then the VCI patients with T2DM were randomly divided into 2 groups. The control group was given routine drug treatment to control blood sugar and improve cognitive function, and the experimental group was treated with acupuncture-rehabilitation therapy on the basis of the control group. Patients in both groups will receive serum biomarkers (superoxide organic dismutase, maleic dialdehyde, brain-derived neurotrophic factor) detection and neuropsychological scale (Montreal Cognitive Assessment, Webster Memory Scale IV Chinese version (adult version), functional independent measurement) evaluation before treatment, 4 weeks, 8 weeks, and 12 weeks after treatment. The functional magnetic resonance imaging scan will be performed again after 12 weeks of treatment. To observe the effect of acupuncture-rehabilitation therapy on cognitive function of VCI patients with T2DM. DISCUSSION: This trial can clarify the effect of acupuncture-rehabilitation therapy on hippocampal volume and its intervention mechanism on oxidative stress injury in VCI patients with T2DM, and clarify the scientific connotation of its neuroprotective mechanism in the VCI patients with T2DM, in order to provide a theoretical basis for the clinical application of acupuncture-rehabilitation therapy in the treatment of VCI. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR), ChiCTR2100047803. Registered 26 June, https://www.chictr.org.cn/showproj.aspx?proj=128707