The Role of Acupuncture-induced Exosome in Treating Post-stroke Dementia

Study Overview
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Brief Summary
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Stroke is the main cause of disability and the second main cause of dementia. Approximately 21.5% of patients develop dementia within 4 years after stroke. The main clinical manifestation of dementia is memory and cognitive impairment. At present, acetylcholinesterase inhibitors and NMDA glutamate receptor antagonists, were used for dementia treatment, but those drugs have limited efficacy. Exosome is an extracellular vesicle from the endosomal, size range from  40 to 160 nm (average  100 nm). It contains many cells including DNA, RNA, fat, and metabolites, as well as cytoplasm and cell surface proteins that play a role in regulating intercellular communication. Some studies believe that exosomes in the circulation are an ideal marker to reflect the pathological progress and recovery of stroke, and play a key role in the reorganization of tissues and the progress of neurodegeneration after stroke. Our previous studies have known that acupuncture can increase the long-term potentiation of hippocampal CA1 in rats with ischemic stroke, and improve learning-memory and neurological function. Therefore, the purpose of this study is to explore the role of acupuncture-induced exosome in the treatment of post-stroke dementia.

Official Title
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The Role of Acupuncture-induced Exosome in Treating Post-stroke Dementia

Conditions
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Exosome, Post-stroke Dementia, Acupuncture

Intervention / Treatment
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* Device: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of stroke. MMSE score between 16 and 26. Exclusion Criteria: Those with serious diseases, such as heart failure, chronic failure or cancer patients, etc. Intolerance to acupuncture treatment. Allergy to acupuncture needles. Refusal to sign the informed consent form.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br> | Device: Acupuncture<br>* The stainless steel needles are used to insert into the three points of Sishencong and the Baihui, and the Dazhui, once a week, once for 20 minutes, for 12 consecutive weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of Exosome |  | 12 weeks | 
| Alzheimer's Disease Assessment Scale-Cognitive Subscale scale | Higher scores indicate greater cognitive impairment. | 12 weeks | 
| Behavioural and Psychological Symptoms of Dementia scale | The greater cognitive impairment or dementia severity is associated with higher rates of some BPSD (Behavioral and psychological symptoms of dementia ). | 12 weeks |