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

NCT05734976 | Unknown DMC

• 1 other identifier: CMUH111-REC1-132
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Acute

Keywords

Stroke; Electroacupunture; Cholesterol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Blood sample: comparable laboratory results:

  First blood sample take at the time of admission, second blood sample taken, completed electroacupuncture treatment 2 weeks, and control 4 weeks

Study Arms (3)

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

EXPERIMENTAL

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

The design and conduct randomized clinical trial using electroacupunture

SHAM COMPARATOR

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

Arm type Methodological challenge in design

NO INTERVENTION

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

Interventions

electroacupuncture DEVICE

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.

Electro-Acupuncture can modulate the levels of pro-inflammatory metabolites; The design and conduct randomized clinical trial using electroacupunture

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Malignant cancer diagnosis
• Traumatic event
• Immunosuppressive patients
• Drug abuse
• Pregnant or lactating women
• Cardiac pacemaker patient

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taichung North Distrit, 40044, Taiwan

Location

Related Publications (11)

• Huzoor-Akbar, Ardlie NG. Platelet activation in haemostasis: role of thrombin and other clotting factors in platelet-collagen interaction. Haemostasis. 1977;6(1):59-71. doi: 10.1159/000214166.

  PMID: 870398 BACKGROUND

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

  PMID: 982095 BACKGROUND

• 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.

  PMID: 36107536 RESULT

• 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.

  PMID: 8841720 RESULT

• Barua NR, Patel AR, Takita H, Jennings EC. Fibrosarcoma of the mediastinum. J Surg Oncol. 1979;12(1):11-7. doi: 10.1002/jso.2930120103.

  PMID: 480950 RESULT

• 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.

  PMID: 2736703 RESULT

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

  PMID: 3919866 RESULT

• Lincoln GA. Pituitary control of testicular activity. Br Med Bull. 1979 May;35(2):167-72. doi: 10.1093/oxfordjournals.bmb.a071565. No abstract available.

  PMID: 387164 RESULT

• Liefshitz B, Parket A, Maya R, Kupiec M. The role of DNA repair genes in recombination between repeated sequences in yeast. Genetics. 1995 Aug;140(4):1199-211. doi: 10.1093/genetics/140.4.1199.

  PMID: 7498763 RESULT

• 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.

  PMID: 134619 RESULT

• Kikindjanin V. Clinical signifcans of longitudinal determination of immunoglobulin values in infants with acut respiratory diseases. Allerg Immunol (Leipz). 1977;23(4):273-80.

  PMID: 147616 RESULT

Related Links

• Stroke: Morbidity, Risk Factors, and Care in Taiwan
• Pathophysiology of Lacunar Stroke: History's Mysteries and Modern Interpretations
• Follow-up study on serum cholesterol profiles and potential sequelae in recovered COVID-19 patients
• 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
• Correlation between Serum Lipid Parameters and Interleukin-10 Concentration in Obese Individuals
• COVID-19-activated SREBP2 disturbs cholesterol biosynthesis and leads to cytokine storm

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief and Attending Physician, Department of Acupuncture, China Medical University Hospital, Taichung, Taiwan.

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: February 21, 2023
• Study Start: September 14, 2022
• Primary Completion: August 13, 2023
• Study Completion: September 13, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)