Clinical trial NCT03097055: Acupuncture Intervention to Improve Neurological Function and Anti-inflammatory Effect in Acute Ischemic Stroke (ANAIS)
Official title: Acupuncture Intervention to Improve Neurological Function and Anti-inflammatory Effect in Patients With Acute Ischemic Stroke (ANAIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Acupuncture
Keywords: Stroke
Acupuncture
antiinflammatory
NIHSS
Lead sponsor: China Medical University, Taiwan
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 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 outcomes:
measure: modified Rankin Scale (mRS)
timeFrame: 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)
measure: Barthel Index
timeFrame: 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)
measure: inflammatory biomarkers
timeFrame: 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)
Other outcomes:
Locations:
city: Nantou City
country: Taiwan
facility: Nantou Hospital of the Ministry of Health and Welfare
state: Nantou County
Study officials:
affiliation: Nantou Hospital of the Ministry of Health and Welfare, Taiwan; China Medical University, Taiwan
name: Chueh-Yi Tsai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University, Taiwan
name: Ching-Liang Hsieh, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: