背景:血管性认知障碍(VCI)持续损害认知和进行日常生活活动的能力,严重影响患者的生活质量。先前的研究报道,血清铁代谢紊乱和大脑中铁沉积可导致炎症,异常的蛋白质聚集和变性,中枢神经系统大量神经元凋亡,这反过来又导致认知过程的逐步下降。我们之前的临床研究发现针灸治疗VCI是一种安全有效的干预措施,但具体机制有待进一步探索。
目的:本试验旨在评价通都醒神针刺法的临床疗效,探讨其是否能通过调节脑铁沉积和机体铁代谢来改善VCI。
方法:总共,42名VCI患者和21名健康个体将参与这项临床试验。将42例VCI患者随机分为针刺组和对照组,而21名健康个体将进入健康对照组。对照组和针刺组均接受常规药物治疗和认知康复训练。此外,针刺组用通度醒神电针治疗,每次30分钟,每周6次,共4周。同时,健康对照组将不接受任何干预。所有3组将接受脑铁沉积的基线评估,血清铁代谢,和入学后的神经心理学测试。针灸组和对照组将在治疗4周结束时再次进行评估,如前所述。通过比较各组之间的神经心理学测试成绩,我们将研究通都醒神针刺治疗VCI的疗效。此外,我们将测试神经心理学测试成绩之间的相关性,脑铁沉积,及机体铁代谢指标,探讨通毒醒神针刺治疗VCI的可能机制。
结果:目前正在招募参与者。第一位参与者于2023年6月注册,这标志着实验的正式开始。截至论文提交之时,有23人参加。招聘过程预计将持续到2025年6月,届时将开始处理和分析数据。截至2024年5月15日,多达30人参加了这项临床试验。
结论:本研究将提供通都醒神针刺对VCI患者脑铁沉积以及躯体铁代谢的影响。这些结果将有助于证明通都醒神针法能否通过调节脑铁沉积和机体铁代谢来改善VCI,为针灸疗法在VCI康复中的广泛应用提供临床和理论依据。
背景:中国临床注册管理机构ChiCTR2300072188;https://tinyurl.com/5fcydtkv.
■PRR1-10.2196/56484。
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: The objective of the trial is 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: In total, 42 patients with VCI and 21 healthy individuals will participate in this clinical trial. The 42 patients with VCI will be randomized into acupuncture and control groups, while the 21 healthy individuals will be in the healthy control group. Both the control and acupuncture groups will receive conventional medical treatment and cognitive rehabilitation training. In addition, the acupuncture group will receive electroacupuncture treatment with Tongdu Xingshen for 30 minutes each time, 6 times a week for 4 weeks. Meanwhile, the healthy control group will not receive any intervention. All 3 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 earlier. 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. As of the submission of the paper, 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. As of May 15, 2024, up to 30 people have been enrolled in this clinical trial.
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. These results will help to prove whether Tongdu Xingshen acupuncture can improve VCI by regulating brain iron deposition and body iron metabolism, which will provide the clinical and theoretical basis for the wide application of acupuncture therapy in VCI rehabilitation.
BACKGROUND: China Clinical Registration Agency ChiCTR2300072188; https://tinyurl.com/5fcydtkv.
UNASSIGNED: PRR1-10.2196/56484.