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

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2014070817867N2
• Date of registration: 2014-09-12
• Prospective Registration: Yes
• Primary sponsor: Tehran University of Medical Sciences
• Public title: Combination of stem cell therapy and non-invasive brain stimulation in acute ischemic stroke
• Scientific title: Addition of transcranial direct current stimulation to autologus bone marrow mononuclear cells transplantation on modified rankin scale score of patients with acute ischemic stroke: a randomized clinical trial
• Date of first enrolment: 2014-10-01
• Target sample size: 15
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/16337
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Shahram Oveisgharan
• Affiliation: Tehran University of Medical Sciences

• Name: Shahram Oveisgharan
• Affiliation: Tehran University of Medical Sciences

Key inclusion & exclusion 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:

Age minimum: 45 years
Age maximum: 85 years
Gender: Both

Health Condition(s) or Problem(s) studied

Ischemic stroke.
Cerebral infarction, unspecified

Cerebral infarction, unspecified

Intervention(s)

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 after the procedure). The bone marrow will be filtered (170 µm blood filter) to remove spicules. The mononuclear cells (BMC) will get enriched by Ficoll-Paque Plus density gradient, and then will be washed by PBS and administered at 1.25% concentration.
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 neurological deficit and location of lesion in MRI: for upper extremity paresis it will be placed over C3, C4; 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 stimul

Placebo

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 neurological deficit and location of lesion in MRI: for upper extremity paresis it will be placed over C3, C4; for lower extremity paresis it will 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. Stimulation parameters: stimulation will be increased from zero to two miliampere within thirty seconds and will be continued for thirty seconds. Then, it will decrease to zero within another thirty seconds. Stimulation will be transferred to patients' skin by sixteen square meters sponges.

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 after procedure). The bone marrow will be filtered (170 µm blood filter) to remove spicules. The mononuclear cells (BMC) will get enriched by Ficoll-Paque Plus density gradient, and then will be washed by PBS and administered at 1.25% concentration.
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 neurological deficit and location of lesion in MRI: for upper extremity paresis it will be placed over C3, C4; 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

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 for one hour after the procedure). The bone marrow will be filtered (170 µm blood filter) to remove spicules. The mononuclear cells (BMC) will get enriched by Ficoll-Paque Plus density gradient, and then will be washed by PBS and administered at 1.25% concentration.
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 neurological deficit and location of lesion in MRI: for upper extremity paresis it will be placed over C3, C4; 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. Stimulation parameters: stimulation will be increased from zero to two miliampere within thirty seconds and will be continued for thirty minutes. Then, it will decrease to zero within another thirty seconds. Stimulation will be transferred to patients' skin by sixteen square meters sponges. Intervention 2: 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 neurological deficit and location of lesion in MRI: for upper extremity paresis it will be placed over C3, C4; for lower extremity paresis it will 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. Stimulation parameters: stimulation will be increased from zero to two miliampere within thirty second

Treatment - Other

Primary Outcome(s)

Functional abilities. Timepoint: Time of discharge, month 1, month 3, month 6. month 12. Method of measurement: Barthel Index.

Functional abilities. Timepoint: Time of discharge, month 1, month 3, month 6. month 12. Method of measurement: Modified Rankin Scale.

Secondary Outcome(s)

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.

Source(s) of Monetary Support

Tehran University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Tehran University of Medical Sciences