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
This study, a randomized single blind clinical trial, will be done to test efficacy and safety of autologous bone marrow-derived mononuclear cell transplantation in combination with transcranial direct current stimulation in treatment of acute ischemic stroke. Inclusion criteria will be ischemic stroke patients who are referred within the first 72 hours after symptoms onset. Patients will be excluded if they have history of previous stroke, history of renal or liver insufficiency, or history of cancer or if they suffer from minor strokes. Study population will be ischemic stroke patients, referred to Shariati hospital, if their conditions are compatible with inclusion and exclusion criteria. Sample size will be 15 patients who will be randomized into three groups. Intervention group one will receive bone marrow-derived mononuclear cell transplantation in combination with active transcranial direct current stimulation. The second intervention group will receive bone marrow-derived mononuclear cell transplantation in combination with sham transcranial direct current stimulation. Control group will receive only sham transcranial direct current stimulation. Primary outcome measure will be functional outcome which will be measured by Modified Rankin Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070817867N2
Registration date:2014-09-12, 1393/06/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-09-12, 1393/06/21
Registrant information
Name
Shahram Oveisgharan
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 6696
Email address
oveis@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-10-01, 1393/07/09
Expected recruitment end date
2015-09-30, 1394/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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
Public title
Combination of stem cell therapy and non-invasive brain stimulation in acute ischemic stroke
Purpose
Treatment
Inclusion/Exclusion 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;
Age
From 45 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
keshavarz blvd
City
tehran
Postal code
Approval date
2013-11-25, 1392/09/04
Ethics committee reference number
92-02-159-23253-97522
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified
Primary outcomes
1
Description
Functional abilities
Timepoint
Time of discharge, month 1, month 3, month 6. month 12
Method of measurement
Modified Rankin Scale
2
Description
Functional abilities
Timepoint
Time of discharge, month 1, month 3, month 6. month 12
Method of measurement
Barthel Index
Secondary outcomes
1
Description
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
2
Description
Burning due to transcranial direct current stimulation application
Timepoint
Time of discharge
Method of measurement
questionnaire
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Placebo
3
Description
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. 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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Shahram Oveisgharan
Street address
Neurology ward, Shariati Hosital, Amirabad St., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Keshavarz blvd., Tehran
City
Tehran
Grant name
Grant code / Reference number
92-02-159-23253
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahram Oveisgharan
Position
Assistant professor of neurology, board of neurology
Other areas of specialty/work
Street address
Neurology ward, Shariati hospital, Amirabad st.
City
Tehran
Postal code
Phone
+98 21 8490 2390
Fax
Email
shogh2@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahram Oveisgharan
Position
Assitant professor of neurology, board of neurology
Other areas of specialty/work
Street address
Neurology ward, Shariati hospital, Amirabad st., Tehran
City
Tehran
Postal code
Phone
+98 21 8490 2390
Fax
Email
shogh2@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahram Oveisgharan
Position
Assistant professor of neurology, board of neurology
Other areas of specialty/work
Street address
Neurology ward, Shariati hospital, Amirabad st., Tehran
City
Tehran
Postal code
Phone
+98 21 8490 2390
Fax
Email
shogh2@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)