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IRCT20190522043673N1 IRCT 2019-08-27 Guilan University of Medical Sciences Effect of tDCS on post-stroke Broca's aphasia Effect of bihemispheric transcranial direct current stimulation on the verbal function of patients with post-stroke Broca's aphasia during the subacute phase 2019-06-22 anticipated 30 Complete https://irct.ir/trial/39923 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be used; with a block size of 4; Allocation concealment will be performed using sealed envelope software. The participants will be allocated to group A or B, using blocked randomization (Block size: 4). One of the groups receive active tDCS, while the other is sham stimulated, neither the participants nor the allocator is not aware that which group will be the treatment group. The physiotherapist, applying the tDCS, is the only researcher who knows the treatment and the sham group. After treatment (or sham stimulation), the data will be analyzed by the statistician, who is either blind to the data groups, Blinding description: The participants will be allocated to group A or B, using blocked randomization. Neither the participants nor the allocator is not aware that which group will be the treatment group. The physiotherapist, applying the tDCS, is the only researcher who knows the treatment and the sham group. After treatment (or sham stimulation), the data will be analyzed by the statistician, who is also blind to the traetment/sham groups. 2-3 post-stroke broca's aphasia. Intervention 1: - Active tDCS (transcranial direct current stimulation); bihemispheric tDCS with 2 mA intensity will be applied for 20 minutes. Anodal stimulation will be applied to the left hemisphere F5 region. Intervention 2: - Sham tDCS; Both electrodes will be placed as in active group. Current will be applied for 3o seconds (10 seconds ramp-up, 10 seconds 2 mA and 10 seconds ramp-down). The electrodes remain in place for 20 minutes but no current will be applied to asses the placebo effect. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Kambiz Rohampour
Guilan University Complex, 6th km of Tehran road,
Rasht Iran (Islamic Republic of) 4193853948 +98 13 3369 0884 rohampour@gmail.com Guilan University of Medical Sciences scientific Alia Saberi
Namjou street, Poursina Hospital
Rasht Iran (Islamic Republic of) 41937-13194 +98 13 3369 0884 Alia.saberi.1@gmail.com Guilan University of Medical Sciences Iran (Islamic Republic of) Incidence of aphasia after ischemic stroke right handed literate (able to read and speak in Persian) able to tolerate the treatment process P-WAB-1 score less than 92 suffering from aphasia based on P-WAB-1 criteria 18 years 80 years Both hemorrhagic stroke tdcs contraindications; metal implants, heart pacemaker, Epilepsy, seizures, taking psychoactive drugs mental illnesses pregnancy brain tumor 169.320 Aphasia following cerebral infarction Treatment - Devices Placebo - Active tDCS (transcranial direct current stimulation); bihemispheric tDCS with 2 mA intensity will be applied for 20 minutes. Anodal stimulation will be applied to the left hemisphere F5 region. - Sham tDCS; Both electrodes will be placed as in active group. Current will be applied for 3o seconds (10 seconds ramp-up, 10 seconds 2 mA and 10 seconds ramp-down). The electrodes remain in place for 20 minutes but no current will be applied to asses the placebo effect. P-WAB-1 score. Timepoint: Before intervention - After intervention - 3 month after intervention. Method of measurement: P-WAB-1 questionnaire. Guilan University of Medical Sciences Approved 2019-05-11 Ethics committee of Guilan University of Medical Sciences Poursina Hospital, Namjou street, Emam blvd. Rasht Guilan Iran (Islamic Republic of)