The Effect of Acupuncture on Brain Iron Deposition and Body Iron Metabolism in Vascular Cognitive Impairment: Protocol for a Randomized Controlled Trial

Overview

Journal JMIR Res Protoc

Publisher JMIR Publications

Specialty General Medicine

Date 2024 Jun 17

PMID 38885500

Authors

Mingli Wu

Lulu Chen

Yamin Wang

Yunpeng Li

Yuqi An

Ruonan Wu

Yuhan Zhang

Jing Gao

Kaiqi Su

Xiaodong Feng

Affiliations

Soon will be listed here.

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: 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.

Trial Registration: China Clinical Registration Agency ChiCTR2300072188; https://tinyurl.com/5fcydtkv.

International Registered Report Identifier (irrid): PRR1-10.2196/56484.

References

Winstein C, Stein J, Arena R, Bates B, Cherney L, Cramer S . Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016; 47(6):e98-e169. DOI: 10.1161/STR.0000000000000098. View

Chen X, Chen L, Chen Q, Fang Z . [Effect of three-line puncture on the Governor Vessel and Bladder Meridian on head on cognitive function of vascular dementia patients]. Zhongguo Zhen Jiu. 2012; 32(4):289-92. View

Bai X, Zhang M . Traditional Chinese Medicine Intervenes in Vascular Dementia: Traditional Medicine Brings New Expectations. Front Pharmacol. 2021; 12:689625. PMC: 8236843. DOI: 10.3389/fphar.2021.689625. View

Toyama K, Spin J, Mogi M, Tsao P . Therapeutic perspective on vascular cognitive impairment. Pharmacol Res. 2019; 146:104266. DOI: 10.1016/j.phrs.2019.104266. View

Creavin S, Wisniewski S, Noel-Storr A, Trevelyan C, Hampton T, Rayment D . Mini-Mental State Examination (MMSE) for the detection of dementia in clinically unevaluated people aged 65 and over in community and primary care populations. Cochrane Database Syst Rev. 2016; (1):CD011145. PMC: 8812342. DOI: 10.1002/14651858.CD011145.pub2. View

Liu C, Li C, Yang J, Gui L, Zhao L, Evans A . Characterizing brain iron deposition in subcortical ischemic vascular dementia using susceptibility-weighted imaging: An in vivo MR study. Behav Brain Res. 2015; 288:33-8. DOI: 10.1016/j.bbr.2015.04.003. View

Rizzi L, Rosset I, Roriz-Cruz M . Global epidemiology of dementia: Alzheimer's and vascular types. Biomed Res Int. 2014; 2014:908915. PMC: 4095986. DOI: 10.1155/2014/908915. View

Tsai C, Lee W, Wang S, Shia B, Nasreddine Z, Fuh J . Psychometrics of the Montreal Cognitive Assessment (MoCA) and its subscales: validation of the Taiwanese version of the MoCA and an item response theory analysis. Int Psychogeriatr. 2011; 24(4):651-8. DOI: 10.1017/S1041610211002298. View

Li Y, Xiong C, Aschenbrenner A, Chang C, Weiner M, Nosheny R . Item response theory analysis of the Clinical Dementia Rating. Alzheimers Dement. 2020; 17(3):534-542. PMC: 8016711. DOI: 10.1002/alz.12210. View

10.

Daglas M, Adlard P . The Involvement of Iron in Traumatic Brain Injury and Neurodegenerative Disease. Front Neurosci. 2019; 12:981. PMC: 6306469. DOI: 10.3389/fnins.2018.00981. View

11.

van der Flier W, Skoog I, Schneider J, Pantoni L, Mok V, Chen C . Vascular cognitive impairment. Nat Rev Dis Primers. 2018; 4:18003. DOI: 10.1038/nrdp.2018.3. View

12.

Weiland A, Wang Y, Wu W, Lan X, Han X, Li Q . Ferroptosis and Its Role in Diverse Brain Diseases. Mol Neurobiol. 2018; 56(7):4880-4893. PMC: 6506411. DOI: 10.1007/s12035-018-1403-3. View

13.

Bo W, Lei M, Tao S, Jie L, Qian L, Lin F . Effects of combined intervention of physical exercise and cognitive training on cognitive function in stroke survivors with vascular cognitive impairment: a randomized controlled trial. Clin Rehabil. 2018; 33(1):54-63. DOI: 10.1177/0269215518791007. View

14.

Dixon S, Lemberg K, Lamprecht M, Skouta R, Zaitsev E, Gleason C . Ferroptosis: an iron-dependent form of nonapoptotic cell death. Cell. 2012; 149(5):1060-72. PMC: 3367386. DOI: 10.1016/j.cell.2012.03.042. View

15.

Hayasaka S, Peiffer A, Hugenschmidt C, Laurienti P . Power and sample size calculation for neuroimaging studies by non-central random field theory. Neuroimage. 2007; 37(3):721-30. PMC: 2041809. DOI: 10.1016/j.neuroimage.2007.06.009. View

16.

Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R . A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015; 385(9984):2255-63. DOI: 10.1016/S0140-6736(15)60461-5. View

17.

Yang Z, Dong S, Zheng Q, Zhang L, Tan X, Zou J . FTY720 attenuates iron deposition and glial responses in improving delayed lesion and long-term outcomes of collagenase-induced intracerebral hemorrhage. Brain Res. 2019; 1718:91-102. DOI: 10.1016/j.brainres.2019.04.031. View

18.

Bao W, Pang P, Zhou X, Hu F, Xiong W, Chen K . Loss of ferroportin induces memory impairment by promoting ferroptosis in Alzheimer's disease. Cell Death Differ. 2021; 28(5):1548-1562. PMC: 8166828. DOI: 10.1038/s41418-020-00685-9. View

19.

Li R, Xu C, Zhong P, Wang K, Luo Y, Xiao L . Efficacy of acupuncture and pharmacological therapies for vascular cognitive impairment with no dementia: a network meta-analysis. Front Aging Neurosci. 2023; 15:1181160. PMC: 10310406. DOI: 10.3389/fnagi.2023.1181160. View

20.

Ravanfar P, Loi S, Syeda W, Van Rheenen T, Bush A, Desmond P . Systematic Review: Quantitative Susceptibility Mapping (QSM) of Brain Iron Profile in Neurodegenerative Diseases. Front Neurosci. 2021; 15:618435. PMC: 7930077. DOI: 10.3389/fnins.2021.618435. View