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

Sponsor
China Medical University Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05734976
Collaborator
(none)
90
1
3
12
7.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: electroacupuncture
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (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
Primary Purpose:
Basic Science
Official Title:
Electroacupuncture on Modifying Inflammatory Levels of Cytokines and Metabolites in Stroke Patients
Actual Study Start Date :
Sep 14, 2022
Anticipated Primary Completion Date :
Aug 13, 2023
Anticipated Study Completion Date :
Sep 13, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Electro-Acupuncture can modulate the levels of pro-inflammatory metabolites

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
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.

Sham Comparator: The design and conduct randomized clinical trial using electroacupunture

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
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.

No Intervention: Arm type Methodological challenge in design

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

Outcome Measures

Primary Outcome Measures

  1. Neurological examination( clinical signs of stroke) [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]

    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

  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]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 China Medical University Hospital Taichung Taichung North Distrit Taiwan 40044

Sponsors and Collaborators

  • China Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Yu-Chen Lee, Chief and Attending Physician, Department of Acupuncture, China Medical University Hospital, Taichung, Taiwan., China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT05734976
Other Study ID Numbers:
  • CMUH111-REC1-132
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yu-Chen Lee, Chief and Attending Physician, Department of Acupuncture, China Medical University Hospital, Taichung, Taiwan., China Medical University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2023