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

Acute Ischemic Stroke Clinical Trial

— ANAIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097055
• Other study ID #: CMUH106-REC1-008
• Status: Completed
• Phase: N/A
• Start date: March 30, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: December 2019
• Source: China Medical University, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 30, 2019
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acupuncture
• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Stroke

Intervention

Procedure:
• Traditional Acupuncture
widely ongoing traditional acupoints in scalp and limbs with traditional "deqi" manipulation, for stroke patient
• Minimal Acupuncture
non-traditional acupoints in scalp and limbs, with minimal manipulation

Locations

Country	Name	City	State
Taiwan	Nantou Hospital of the Ministry of Health and Welfare	Nantou City	Nantou County

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)