Ischemic stroke. Cerebral infarction, unspecified
Conditions
Interventions
Intervention 1: First intervention group: a total of two ml/kg bone marrow will be harvested from posterior iliac bone (blood pressure, heart rate, and oxygen saturation will be monitored during and f
for lower extremity paresis it will be placed over Cz
for Broca aphasia it will be placed over F7. Cathod electrodes will be placed over contralateral supraorbital area. Stimulation will be delivered by use of a battery-driven constant current stimulator
for lower extremity paresis it will placed over Cz
Treatment - Other
Placebo
First intervention group: a total of two ml/kg bone marrow will be harvested from posterior iliac bone (blood pressure, heart rate, and oxygen saturation will be monitored during and for one hour afte
for Broca aphasia it will be placed over F7. Cathod electrodes will be placed over contralateral supraorbital area. Stimulation will be delivered by use of a battery-driven constant current stimul
Control group: transcranial Direct Current Stimulation (tDCS) will be administered since the day after BMC administration twice daily for 10 days. Anode electrode will be placed according to the main
Second intervention group: a total of two ml/kg bone marrow will be harvested from posterior iliac bone (blood pressure, heart rate, and oxygen saturation will be monitored during and for one hour aft
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
45 Years to 85 Years
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| National 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShahram Oveisgharan
Tehran University of Medical Sciences
Outcome results
None listed