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

Primary Purpose

Ischemic Stroke, Acute

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
electroacupuncture
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ischemic Stroke focused on measuring Stroke, Electroacupunture, Cholesterol

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Electro-Acupuncture can modulate the levels of pro-inflammatory metabolites

The design and conduct randomized clinical trial using electroacupunture

Arm type Methodological challenge in design

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
December 7, 2022
Last Updated
February 19, 2023
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05734976
Brief Title
Electroacupuncture on Modifying Inflammatory Levels of Cytokines and Metabolites in Stroke Patients.
Official Title
Electroacupuncture on Modifying Inflammatory Levels of Cytokines and Metabolites in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
August 13, 2023 (Anticipated)
Study Completion Date
September 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Acute
Keywords
Stroke, Electroacupunture, Cholesterol

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
The measure in this study is the change in Visual Analog Scale (VAS), National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), after completing 2 weeks of electroacupuncture. Clinical measurements are made; blood tests to show the results of the treatment
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electro-Acupuncture can modulate the levels of pro-inflammatory metabolites
Arm Type
Experimental
Arm Description
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.
Arm Title
The design and conduct randomized clinical trial using electroacupunture
Arm Type
Sham Comparator
Arm Description
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
Arm Title
Arm type Methodological challenge in design
Arm Type
No Intervention
Arm Description
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
Intervention Type
Device
Intervention Name(s)
electroacupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neurological examination( clinical signs of stroke)
Description
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.
Time Frame
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 Measure Information:
Title
Blood sample: comparable laboratory results:
Description
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).
Time Frame
First blood sample take at the time of admission, second blood sample taken, completed electroacupuncture treatment 2 weeks, and control 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
State/Province
Taichung North Distrit
ZIP/Postal Code
40044
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
http://doi.org/10.5853/jos.2014.16.2.59
Description
Stroke: Morbidity, Risk Factors, and Care in Taiwan
URL
http://doi.org/10.1016/j.jstrokecerebrovasdis.2019.05.006
Description
Pathophysiology of Lacunar Stroke: History's Mysteries and Modern Interpretations
URL
http://doi.org/10.1186/s12879-021-05984-1
Description
Follow-up study on serum cholesterol profiles and potential sequelae in recovered COVID-19 patients
URL
http://doi.org/10.1038/s41598-021-81730-6
Description
An evaluation of lipid profle and pro-infammatory cytokines as determinants of cardiovascular disease in those with diabetes: a study on a Mexican American cohort
URL
http://doi.org/10.7570/jomes20122
Description
Correlation between Serum Lipid Parameters and Interleukin-10 Concentration in Obese Individuals
URL
http://doi.org/10.1038/s41392-020-00292-7
Description
COVID-19-activated SREBP2 disturbs cholesterol biosynthesis and leads to cytokine storm

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

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