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Acupuncture Intervention to Improve Neurological Function and Anti-inflammatory Effect in Acute Ischemic Stroke (ANAIS) (ANAIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03097055
Recruitment Status : Active, not recruiting
First Posted : March 31, 2017
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Tsai Chueh-Yi, China Medical University, Taiwan

Brief Summary:
This study will have acupuncture intervention in acute ischemic stroke patients and evaluate the effect in neurological function improving by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS), Barthel Index, and antiinflammatory actions by biomarkers.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Acupuncture Procedure: Traditional Acupuncture Procedure: Minimal Acupuncture Not Applicable

Detailed Description:

Acupuncture Treatment in Stroke is a widely practiced in Taiwan, mainland China, and around the world. The using in stroke group is countless. Numerous clinical trials have been conducted in the medical community to assess efficacy, and the results mostly suggest that acupuncture may be an effective, low side effects adjuvant therapy. Ischemic stroke is also associated with chronic inflammation-related diseases. In recent years, the anti-inflammatory effect of acupuncture was gradually found. So, whether in the basic or in clinical, the investigators can deduce that acupuncture may be helpful for stroke as an adjuvant therapy.

This study evaluates the neurological function of patients with acute stroke by using the widely used National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS) and Barthel Index. Also, the investigators assess the degree of inflammation by biomarkers. Therefore, the purpose of this study is to explore the effect of acupuncture intervention on acute ischemic patients and its relationship in anti-inflammatory actions.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture Intervention to Improve Neurological Function and Anti-inflammatory Effect in Patients With Acute Ischemic Stroke (ANAIS)
Actual Study Start Date : March 30, 2017
Actual Primary Completion Date : December 18, 2018
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Traditional Acupuncture
Traditional acupoints and traditional "deqi" manipulation
Procedure: Traditional Acupuncture
widely ongoing traditional acupoints in scalp and limbs with traditional "deqi" manipulation, for stroke patient

Sham Comparator: Minimal Acupuncture
To avoid traditional acupoints and minimal manipulation
Procedure: Minimal Acupuncture
non-traditional acupoints in scalp and limbs, with minimal manipulation




Primary Outcome Measures :
  1. National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 1.beginning of stroke (within 3 days after onset); 2.after a 4-weeks acupuncture course (within 7 days after last acupuncture); 3. a month later after acupuncture course (about 28±7 days after last acupuncture) ]
    The NIHSS improving in about a 2-months-period follow up.


Secondary Outcome Measures :
  1. modified Rankin Scale (mRS) [ Time Frame: 1.beginning of stroke (within 3 days after onset); 2.after a 4-weeks acupuncture course (within 7 days after last acupuncture); 3. a month later after acupuncture course (about 28±7 days after last acupuncture) ]
    The mRS improving in about a 2-months-period follow up.

  2. Barthel Index [ Time Frame: 1.beginning of stroke (within 3 days after onset); 2.after a 4-weeks acupuncture course (within 7 days after last acupuncture); 3. a month later after acupuncture course (about 28±7 days after last acupuncture) ]
    The Barthel Index improving in about a 2-months-period follow up.

  3. inflammatory biomarkers [ Time Frame: 1.beginning of stroke (within 3 days after onset); 2.after a 4-weeks acupuncture course (within 7 days after last acupuncture); 3. a month later after acupuncture course (about 28±7 days after last acupuncture) ]
    The inflammatory biomarkers changing in about a 2-months-period follow up.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically diagnosed acute ischemic stroke
  • Initial NIHSS between 4~20
  • Aged 45 ~ 85

Exclusion Criteria:

  • Hemorrhagic transformation after cerebral infarction, the hemorrhage size estimated to be ≥ 2cm in diameter by brain imaging.
  • Any intracranial hemorrhage , except hemorrhagic transformation after cerebral infarction
  • Any intracranial operation during acute stage
  • Patient using anticoagulants
  • Cerebellar infarction
  • Special causes of stroke, such as coagulation abnormalities, or arteriovenous malformations
  • Epileptic seizures after stroke
  • Combined with infection diseases at the time of assessment
  • Pregnant or breastfeeding women
  • Present mental illness or symptoms and cannot cooperate with the study
  • Cannot sign the inform consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097055


Locations
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Taiwan
Nantou Hospital of the Ministry of Health and Welfare
Nantou City, Nantou County, Taiwan, 540
Sponsors and Collaborators
China Medical University, Taiwan
Investigators
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Principal Investigator: Chueh-Yi Tsai, MD Nantou Hospital of the Ministry of Health and Welfare, Taiwan; China Medical University, Taiwan
Principal Investigator: Ching-Liang Hsieh, MD/PhD China Medical University, Taiwan

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Responsible Party: Tsai Chueh-Yi, Master Student, China Medical University, Taiwan
ClinicalTrials.gov Identifier: NCT03097055     History of Changes
Other Study ID Numbers: CMUH106-REC1-008
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tsai Chueh-Yi, China Medical University, Taiwan:
Stroke
Acupuncture
antiinflammatory
NIHSS

Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Anti-Inflammatory Agents