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IRCT20210118050075N1 IRCT 2021-04-22 Tabriz University of Medical Sciences Study on effect of photobiomodulation on stroke induced Broca aphasia Study on effect of transcranial light stimulation on the linguistic performance of patients with ischemic stroke induced Broca aphasia 2021-04-09 anticipated 20 Complete https://irct.ir/trial/53894 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: For All referred and eligible patients in order to enter the study will be allocated 2-digit code from 01 to 20. Then will be used (en.calc-site.com/randoms/grouping) website، which its output is as numbers, first 10 codes for sham group and remaining 10 patients will be in intervention group with a 1:1 ratio, Blinding description: In intervention group, laser transmission will be applied on F3 and F4 regions (according to EEG standards) by placing the related equipment, but in control or sham group the same protocol will be used but the laser illumination will be inactive. Because the illumination of infrared laser is invisible, the patient is not able to see the light that can suggest the type of intervention. N/A Condition 1: Stroke. Condition 2: Aphasia. Condition 3: transcranial photobiomodulation. Condition 4: transcranial infrared laser brain stimulation. Intervention 1: Infrared laser with wavelength of 810 nanometer will be transmitted in intervention group for 6 minutes, 2 times a week, in a period of 6 weeks from the F3 and F4 regions according to EEG with radiation of 300 mW/cm2. In all studied cases, routine speech therapy will be continued in the sessions. Intervention 2: In control or sham group, the same process of intervention group will be done but the laser will be off. In all studied cases, routine speech therapy will be continued in the sessions. Yes - There is a plan to make this available What will be shared: Data without participants names as coded data can be available. When: After finishing of the project, analysis and publication of the thesis To whom: University and industry researchers Conditions: For research to promote the effect of intervention and or designing of the laser system Where to obtain: Tabriz Neurosciences Research Center How to obtain: After official request and clarification of the needed data and the aims, the data can be available during 1 month if the the project has already finished. Comments: The material and intellectual property rights of the Neurosciences Research Center and the researchers should be considered.
public Ali Sangnourpour
Medical Faculty, Gholghasht Street, Azadi Avenue
Tabriz Iran (Islamic Republic of) 5157735573 +98 41 3320 1225 a.sangnour@gmail.com Tabriz University of Medical Sciences scientific Saeed Sadigetegad
Neurosciences Research Center, Imam Reza Hospital, Gholghasht Street, Azadi Avenue
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 0730 saeed.sadigetegad@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients of both genders Age range 18–60 years Right handness Aphasia induced by stroke Stroke due to upper branch of middle cerebral artery involvement Unilateral stroke Broca type aphasia NIHSS stroke severity of 7-15 19 years 85 years Both More than one stroke Seizure Sustained hypotension or hypertension Septic emboli Known hereditary or acquired hemorrhagic diathesis Skin disorder at the site of light transmission Severe mental deficit or other neurological deficit or disorder (eg. dementia, multiple sclerosis) Life threatening such as unstable cardiac arrhythmia, pulmonary emboli, gastrointestinal bleeding and pneumonia Receiving thrombolytic treatment for the acute ischemic stroke I63.9 I69.820 Cerebral infarction, unspecified Aphasia following other cerebrovascular disease Treatment - Devices Treatment - Devices Infrared laser with wavelength of 810 nanometer will be transmitted in intervention group for 6 minutes, 2 times a week, in a period of 6 weeks from the F3 and F4 regions according to EEG with radiation of 300 mW/cm2. In all studied cases, routine speech therapy will be continued in the sessions. In control or sham group, the same process of intervention group will be done but the laser will be off. In all studied cases, routine speech therapy will be continued in the sessions. Aphasia severity. Timepoint: At the start of study and 6 weeks later. Method of measurement: Bilingual aphasia test (BAT). Tabriz University of Medical Sciences Approved 2020-11-08 Local Ethic Committee of Tabriz University of Medical Sciences No. 2 Central Office of Tabriz University of Medical Sciences, 3th Floor, Gholghasht Street, Azadi Avenue Tabriz East Azarbaijan Iran (Islamic Republic of)