Electroacupuncture on Modifying Inflammatory Levels of Cytokines and Metabolites in Stroke Patients.

Study Overview
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Brief Summary
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The study will make an association between the diagnosis of traditional Chinese medicine that establishes that the syndrome of blood stagnation generates alteration in blood flow, vascular dysfunction, and damage to the endothelium. This process is like what occurs in a stroke. It will use electroacupuncture to change this chronic inflammatory process, and to know the effects and efficacy of this technique in the regulation and modulation of to treat extensive inflammatory diseases. However, this inflammatory response must be associated with serum cholesterol levels, since they are associated with a stroke between the LDL-C/HDL-C ratio and the prognosis after a stroke.

Detailed Description
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An adequate early standardized diagnosis of ischemic stroke uses different treatment protocols for these patients, depending on their complexity. Therapeutic windows have been associated with better outcomes when reperfusion or recanalization occurs. Someone has shown strongly related clinical outcome in ischemic stroke to the timely revascularization benefit of acupuncture in stroke patients; electroacupuncture intervention on metabolism is associated with effects on the anti-inflammatory mechanism and metabolic modulation, effects of electroacupuncture stimulation at different spinal segmental levels in a rat model of diabetes mellitus, and another vascular effect of electroacupuncture generate the modulation of the elasticity of the blood vessels. Electroacupuncture (EA) stimulation is commonly applied in the treatment of ischemic stroke in the clinic. The efficacy of EA is associated with the acupuncture points, intensity, intervals, and duration of the intervention of the treatment for stroke. The inflammatory response might be associated with serum cholesterol levels since they are associated with a stroke between the LDL-c/HDL-c ratio and the prognosis after a stroke. This study evaluates the impact of electroacupuncture as a modifier of total cholesterol, HDL-c, and LDL-c blood levels and its anti-inflammatory effect in patients with cerebrovascular accidents. Measurement of the post-electroacupuncture serum level (total cholesterol, HDL-c, LDL-c, and triglycerides) will provide adequate information on the influence that these risk factors have on blood vessels and vascular endothelium.

Official Title
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Electroacupuncture on Modifying Inflammatory Levels of Cytokines and Metabolites in Stroke Patients

Conditions
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Acute, Ischemic Stroke

Intervention / Treatment
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* Device: electroacupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of patients with acute ischemic stroke Stroke diagnosed for the first time Must be able to respond to simple commands and tolerate the electroacupuncture Exclusion Criteria: Malignant cancer diagnosis Traumatic event Immunosuppressive patients Drug abuse Pregnant or lactating women Cardiac pacemaker patient

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is clinical trialrandomized in electroacupuncture: use a control group and treatment group design(included sharm acupuncture) Practice mainly based on medical experience and evidence from clinical cases of CMUH.clinical measurements are made; blood tests to evidence treatment results.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electro-Acupuncture can modulate the levels of pro-inflammatory metabolites<br>the disproportionate inflammatory response presented by chronic and acute inflammation as is the case in patients with stroke. In addition, the evaluation of the risk factors associated with the presence of metabolites such as cholesterol and fatty acids will provide us with an adequate diagnosis of the influence that these risk factors have on the blood vessels and the vascular endothelium.This is the group that receives real electroacupuncture, applied to selected acupuncture points both on the arms and legs, and on the scalp. All procedures were carried out with disposable needles measuring 0.25 mm in diameter (32-gauge) and 44 mm in length. | Device: electroacupuncture<br>* This is the group that receives real electroacupuncture, applied to selected acupuncture points both on the arms and legs, and on the scalp. All procedures were carried out with disposable needles measuring 0.25 mm in diameter (32-gauge) and 44 mm in length.<br>|
| Sham Comparator: The design and conduct randomized clinical trial using electroacupunture<br>efficacy and effectiveness of electroacupuncture in a clinical trial in electroacupuncture: design of control group and treatment group (including sharm acupuncture) and develop in this study the measurements in the patients and perform everything to the highest standards in both treatment procedures and measurement of results. Randomized controlled trail: intervention strategy and implementation.Also called Sham because it does not receive real stimulation from an acupuncture point, it is 1 cm away from the meridian. All procedures were carried out to a depth of 0.5 cm with disposable needles | Device: electroacupuncture<br>* This is the group that receives real electroacupuncture, applied to selected acupuncture points both on the arms and legs, and on the scalp. All procedures were carried out with disposable needles measuring 0.25 mm in diameter (32-gauge) and 44 mm in length.<br>|
| No Intervention: Arm type Methodological challenge in design<br>Electroacupuncture treatment, develops different groups study are three; electroacupuncture group or real treatment,1st control group or Participants in the sham group also received 24 sessions of acupuncture treatment; however, needling was performed 1 cm away from the real acupoints and 2nd control group or non-penetration needles. Access to medical records; to collect data and store it securely and anonymously.this group will receive treatment at 6 acupuncture points, but without penetration, without electroacupuncture, this is why it is called the control group. Use disposable needles too | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological examination( clinical signs of stroke) | National Institutes of Health Stroke Scale (NIHSS) score of 0 40. Barthel Index (BI) score of:0 100.The National Visual Analog Scale (VAS) score of: 0 10. | This assessment can be used before and after the electroacupuncture treatment period (1 week, 2 weeks, 4 weeks) stroke patient's ability and independence to care for themselves | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood sample: comparable laboratory results: | Total cholesterol,triglycerides,HDL cholesterol,LDL cholesterol.For routine analyses, the extraction time of blood is between 7 and 9:30 a.m. without previous food They are used for the initial measurement of cholesterol levels in the blood and to monitor and compare these levels once the treatment of EA, Sham and the control group has finished (check blood cholesterol levels). | First blood sample take at the time of admission, second blood sample taken, completed electroacupuncture treatment 2 weeks, and control 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Electroacupunture, Cholesterol