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临床试验/CTRI/2025/06/088009
CTRI/2025/06/088009招募中2/3 期

Effect of Electro-acupuncture at Siguan points (Four Gate points) on Cognitive functions of Post Stroke Rehabilitation Patients: A Quasi Experimental Study

International Institute Of Yoga And Naturopathy Medical Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月11日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
MoCA test

研究概览

简要总结

Stroke is the third leading cause of disability-adjusted life years globally, with about one-fifth of stroke survivors experiencing disabilities three months post-stroke. Cognitive impairments, including mild cognitive impairment (MCI) and dementia, are common post-stroke, with prevalence rates of 37% and 21%, respectively, within 3 to 6 months. The hippocampus, a key region for mood and cognition, is particularly vulnerable to ischemia/reperfusion injury. Acupuncture, a traditional Chinese medicine technique, has shown therapeutic benefits in post-stroke rehabilitation. Specifically, the Siguan acupoints (LI4 and Liv3), widely used for neurological and cognitive disorders, have demonstrated effectiveness in improving cognitive functions. Electro-acupuncture (EA) at Siguan points has been found to exert antidepressant effects comparable to fluoxetine in preclinical studies. This study aims to evaluate the efficacy of EA at Siguan points on cognitive function in post-stroke rehabilitation patients with mild to moderate cognitive impairment within one year of stroke onset. If successful, the findings could support the use of this cost-effective and minimally invasive intervention to prevent the progression of MCI to dementia in stroke survivors.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants will include adults aged 30 to 60 years who have been diagnosed with ischemic or hemorrhagic stroke confirmed by imaging (CT or MRI), with stroke onset occurring within the past 3 to 12 months.
  • Eligible individuals will have mild to moderate cognitive impairment, as assessed by the Montreal Cognitive Assessment (MoCA), and a stable medical condition without severe complications or comorbidities.
  • Participants must be actively involved in a stroke rehabilitation program, demonstrate sufficient functional mobility to attend study visits and participate in therapy sessions, and must not have received acupuncture treatment within the past month.

排除标准

  • Patients with severe cardiac, hepatic, renal, or respiratory diseases, as well as those with poorly controlled hypertension or diabetes.
  • Individuals with severe strokes causing significant impairments, severe cognitive impairments, pre-existing dementia, or severe mental health disorders such as schizophrenia, bipolar disorder, or severe depression will also be excluded.
  • Pregnant or lactating women, patients who have experienced another stroke within the last three months, or those currently undergoing conflicting therapies such as other forms of acupuncture, intensive physiotherapy, or cognitive rehabilitation are not eligible.

结局指标

主要结局

MoCA test

时间窗: Baseline assessment 1 month

次要结局

  • Visual Reaction Time and Auditory Reaction Time(Baseline assessment)

研究者

发起方
International Institute Of Yoga And Naturopathy Medical Sciences
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ishwariyaa S

International Institute Of Yoga And Naturopathy Medical Sciences, Chengalpattu

研究点 (1)

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