NCT03097055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

1.7 years

First QC Date

March 21, 2017

Last Update Submit

December 8, 2019

Conditions

Acute Ischemic StrokeAcupuncture

Keywords

StrokeAcupunctureantiinflammatoryNIHSS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • modified Rankin Scale (mRS)

    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

    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

    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)

Study Arms (2)

Traditional Acupuncture

EXPERIMENTAL

Traditional acupoints and traditional "deqi" manipulation

Procedure: Traditional Acupuncture

Minimal Acupuncture

SHAM COMPARATOR

To avoid traditional acupoints and minimal manipulation

Procedure: Minimal Acupuncture

Interventions

Traditional AcupuncturePROCEDURE

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

Traditional Acupuncture
Minimal AcupuncturePROCEDURE

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

Minimal Acupuncture

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantou Hospital of the Ministry of Health and Welfare

Nantou City, Nantou County, 540, Taiwan

Location

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 31, 2017

Study Start

March 30, 2017

Primary Completion

December 18, 2018

Study Completion

September 30, 2019

Last Updated

December 10, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)