Combination of stem cell therapy and non-invasive brain stimulation in acute ischemic stroke
- 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
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;
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.