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Combination of stem cell therapy and non-invasive brain stimulation in acute ischemic stroke

Not Applicable
Conditions
Ischemic stroke.
Cerebral infarction, unspecified
Registration Number
IRCT2014070817867N2
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
15
Inclusion Criteria

Ischemic stroke patients will be included: if they are referred to recruitment center within their first 72 hours after symptoms onset; if they are between 45 to 85 years old; if their cell transplantation procedure get completed within 72 hours after stroke symptoms onset; if their stroke locations are in hemispheres, not in cerebellum or brain stem.
Ischemic stroke patients will be excluded: if they have foreign metallic bodies in their head; if they suffer from previous stroke in their history or imaging; if they have history of cancer; if they have moderate to severe lung disease (Chronic Obstructive Pulmonary Disease or Asthma); if they have history of severe heart failure (class IV in the New York Heart Association Functional Capacity); if they have history of previous stem cell transplantation or history of chemotherapies; if they have uncorrected coagulopathy (which is defined as International Normalized Ratio greater than 1.4 or Partial Thromboplastin Time greater than 40 seconds); if they have pre-stroke dementia; if they or their relatives do not sign consents; if they need others’ help in activities of daily livings before their stroke; if they are pregnant; if they have history of renal insufficiency (which is defined as serum creatinine greater than 1.4 mg/dl); if they have history of liver insufficiency (which is defined as serum hepatic enzymes more than three times above upper limits of normal ranges); if they have National Institutes of Health Stroke Scale score less than four; if they get scores greater than one in the first question of National Institute of Health Stroke Scale (level of consciousness); if they are involved in another clinical trial;

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Functional abilities. Timepoint: Time of discharge, month 1, month 3, month 6. month 12. Method of measurement: Modified Rankin Scale.;Functional abilities. Timepoint: Time of discharge, month 1, month 3, month 6. month 12. Method of measurement: Barthel Index.
Secondary Outcome Measures
NameTimeMethod
ational Institutes of Health Stroke Scale (NIHSS) score. Timepoint: Time of admission, time of discharge, month 1, month 3, month 6. month 12. Method of measurement: National Institutes of Health Stroke Scale.;Burning due to transcranial direct current stimulation application. Timepoint: Time of discharge. Method of measurement: questionnaire.
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