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NCT Number: NCT03097055

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

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.

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Key information

Conditions

Acute Ischemic Stroke Acupuncture Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantou Hospital of the Ministry of Health and Welfare

Nantou City, Nantou County, 540, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional Acupuncture

Procedure

widely ongoing traditional acupoints in scalp and limbs with traditional "deqi" manipulation, for stroke patient

Minimal Acupuncture

Procedure

non-traditional acupoints in scalp and limbs, with minimal manipulation

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

China Medical University, Taiwan

Other

Registry information

Official study title

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

Acronym: ANAIS

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 31, 2017
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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