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IRCT20190927044895N1 IRCT 2019-10-28 Zanjan University of Medical Sciences Efficacy of transcranial direct current stimulation(tDCS) on stroke Efficacy of transcranial direct current stimulation(tDCS) on functional connectivity, motor learning and cognitive functions in ischemic stroke patients: Double blind randomized clinical trail 2019-09-28 anticipated 45 Complete https://irct.ir/trial/42561 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This clinical trial consists of three groups: real intervention, sham and control, double-blind and randomized, Randomization description: Blocked randomization, individual, layered, statistical software. A sample of 45 ischemic stroke patients was randomly accessed through the Web at https://www.sealedenvelope.com, The 15 ABC triplicate blocks were assigned by the supervisor in three 15-person in three groups, Blinding description: 1- Patients do not know in which intervention group ABC (real intervention, sham and control) are. 2- Data analysis is performed by medical imaging systems team. As they are not aware of the nature of the ABC groups. All data will be encoded. N/A Ischemic Stroke. Intervention 1: Intervention group one: The real stimulation was 2.0 mA for 30 minutes in the primary motor cortex, then 30 minutes rest without intervention and at the end real stimulation was performed 2.0 mA for 30 minutes in the dorsolateral prefrontal cortex. The intervention consists of 12 therapeutic sessions per day. Intervention 2: Intervention group two: Sham stimulation 2 mA after 60 seconds is interrupted in the patient's primary motor cortex, then 30 minutes rest without intervention and finally sham stimulation 2 mA after 60 seconds in the dorsolateral prefrontal cortex of the patient. The intervention consists of 12 therapeutic sessions per day. Intervention 3: Control group: No intervention. Yes - There is a plan to make this available What will be shared: All of information related to main outcome will be published. When: Start the access period from 2020 To whom: Researchers and clinicians working in academic and scientific institutions Conditions: Access to documents is possible to inform other researchers and clinicians. Access to documents is possible to work with the researcher. Where to obtain: DR. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Dr Mohsen Dadashi, Mobile: 0098 9127433559. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology,Ahmadreza Zakerian Zadeh, Mobile: 0098 9177432214 How to obtain: Documents will be shared only when the reason for the request is announced by phone or e-mail.Response time is seven days. Comments:
public Mohsen Dadashi
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
Zanjan Iran (Islamic Republic of) 45136-15788 +98 24 3354 2403 psy.mohsen@zums.ac.ir Zanjan University of Medical Sciences scientific Ahmadreza Zakerian Zadeh
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
Zanjan Iran (Islamic Republic of) 15788-45136 +98 24 3354 2403 Ahmadrezazakerian@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Having informed consent to participate in the study. A chronic stroke patient (> 3 months) diagnosed by imaging. Having at least 40 and up to 80 years of age and right-handedness. Having spent at least 3 months since infarction. Having a marked motor deficiency in the upper and lower extremities with cerebrovascular injury. Having at least mild cognitive impairment based on measuring instruments. Having mild depression symptoms based on the hamilton depression rating scale. 40 years 80 years Both 1- Suicidal thoughts or risks that could not maintain stable dose of medication. Psychiatric disorder and drug use. Having a history of head injury and epileptic seizures, Epilepsy and head injury and pregnancy. Having no use of tDCS or fMRI. G46.4 Cerebellar stroke syndrome Rehabilitation Rehabilitation N/A Intervention group one: The real stimulation was 2.0 mA for 30 minutes in the primary motor cortex, then 30 minutes rest without intervention and at the end real stimulation was performed 2.0 mA for 30 minutes in the dorsolateral prefrontal cortex. The intervention consists of 12 therapeutic sessions per day. Intervention group two: Sham stimulation 2 mA after 60 seconds is interrupted in the patient's primary motor cortex, then 30 minutes rest without intervention and finally sham stimulation 2 mA after 60 seconds in the dorsolateral prefrontal cortex of the patient. The intervention consists of 12 therapeutic sessions per day. Control group: No intervention Functional connectivity. Timepoint: Pre-test, Post-test. Method of measurement: Functional Magnetic Resonance Imaging. Motor Learning. Timepoint: Pre-test, Post-test and follow up (one month after post-test). Method of measurement: Fugl-Meyer Test. Cognitive functions. Timepoint: Pre-test, Post-test and follow up (one month after post-test). Method of measurement: Montreal Cognitive Assessment. Depression. Timepoint: Pre-test, Post-test and follow up (one month after post-test). Method of measurement: Hamilton Depression Rating Scale. Attention. Timepoint: Pre-test, Post-test and follow up (one month after post-test). Method of measurement: Selective and Divided Attention Test. Balance. Timepoint: Pre-test, Post-test and follow up (one month after post-test). Method of measurement: Berg Balance Scale. Zanjan University of Medical Sciences Approved 2019-07-29 Ethics committee of Zanjan University of Medical Sciences Azadi Square, Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)