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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acute Ischemic Stroke, Acupuncture

Intervention / Treatment
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* Procedure: Traditional Acupuncture
* Procedure: Minimal Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional Acupuncture<br>Traditional acupoints and traditional deqi manipulation | Procedure: Traditional Acupuncture<br>* widely ongoing traditional acupoints in scalp and limbs with traditional deqi manipulation, for stroke patient<br>|
| Sham Comparator: Minimal Acupuncture<br>To avoid traditional acupoints and minimal manipulation | Procedure: Minimal Acupuncture<br>* non-traditional acupoints in scalp and limbs, with minimal manipulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health Stroke Scale (NIHSS) | The NIHSS improving in about a 2-months-period follow up. | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale (mRS) | The mRS improving in about a 2-months-period follow up. | 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) | 
| Barthel Index | The Barthel Index improving in about a 2-months-period follow up. | 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) | 
| inflammatory biomarkers | The inflammatory biomarkers changing in about a 2-months-period follow up. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Acupuncture, antiinflammatory, NIHSS