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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05734976
• Other study ID #: CMUH111-REC1-132
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 14, 2022
• Est. completion date: September 13, 2023

Study information

• Verified date: February 2023
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: September 13, 2023
• Est. primary completion date: August 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of patients with acute ischemic stroke

2. Stroke diagnosed for the first time

3. Must be able to respond to simple commands and tolerate the electroacupuncture

Exclusion Criteria:

1. Malignant cancer diagnosis

2. Traumatic event

3. Immunosuppressive patients

4. Drug abuse

5. Pregnant or lactating women

6. Cardiac pacemaker patient

Related Conditions & MeSH terms

• Acute
• Ischemic Stroke
• Stroke

Intervention

Device:
• electroacupuncture
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.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung	Taichung North Distrit

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (11)

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Duan JY. [Anti-inflammatory and immunologic actions of buyang huanwu tang]. Zhong Xi Yi Jie He Za Zhi. 1989 Mar;9(3):164-6, 134. Chinese. — View Citation

How J, West D, Edmonds C. Decompression sickness in diving. Singapore Med J. 1976 Jun;17(2):92-7. No abstract available. — View Citation

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Scots lead the way on alcohol. Br Med J (Clin Res Ed). 1985 Mar 30;290(6473):952-3. No abstract available. — View Citation

Sekhar LN, Gormley WB, Wright DC. The best treatment for vestibular schwannoma (acoustic neuroma): microsurgery or radiosurgery? Am J Otol. 1996 Jul;17(4):676-82; discussion 683-9. No abstract available. — View Citation

Tewari HB, Sethi JS. Chemo-architectonic studies in a submammalian brain. Adenosine triphosphatase and simple esterase in the diencephalon and mesencephalon. Acta Anat (Basel). 1976;95(3):321-48. — View Citation

Xu Y, Zhong DY, Liao XQ, Wang XP, Ge JW, Xu WH. Acupuncture against the metabolic risk factors for stroke: A systematic review of systematic reviews. Medicine (Baltimore). 2022 Sep 2;101(35):e30086. doi: 10.1097/MD.0000000000030086. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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•   Pathophysiology of Lacunar Stroke: History's Mysteries and Modern Interpretations
•   Stroke: Morbidity, Risk Factors, and Care in Taiwan