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IRCT20211030052912N1 IRCT 2021-11-11 University of social welfare and rehabilitation sciences Evaluation of the effect of adding direct transcranial stimulation (tDCS) of Dorsolateral Prefrontal Cortex to primary motor cortex on spasticity and improvement of upper limb motor function in patients with chronic stroke: A double-blind controlled clinical trial Evaluation of the effect of adding direct transcranial stimulation (tDCS) of Dorsolateral Prefrontal Cortex to primary motor cortex on spasticity and improvement of upper limb motor function in patients with chronic stroke: A double-blind controlled clinical trial 2021-12-19 anticipated 42 Complete https://irct.ir/trial/59855 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done through Randomization.com. According to the two intervention groups (A) and control (B), six Quadriple blocks will be used in this method. Each sequence is then recorded on a card and placed in an envelope. In order of patients' arrival, the envelopes are opened and the assigned group of the participant is determined, Blinding description: In this double-blind study, patients and evaluators are unaware of the type of group assigned. Randomization and intervention will be performed by a person who is not involved in the patient evaluation process and the evaluator is unaware of the type of intervention. N/A Stroke. Intervention 1: Intervention group: Anodal stimulation of the M1 and pDLPFC of the involved side. To create electrical brain movements, 2 devices of a tDCS channel, model Activados, made in the USA will be used. Active electrodes according to the involved side, is left M1( c3) and DLPFC( F3) or right m1 (c4) and DLPFC ( F4 ) and reference electrodes will be placed on the contralateral of superorbital . Constant current with an intensity of 1 mA for 20 minutes with active electrode of 16 cm2 and a reference electrode of 35 cm2 will be used. Intervention 2: Control group: Real anodal stimulation of the primary motor cortex and sham stimulation of the Dorsolateral prefrontal cortex involved side. To create electrical stimulation of the brain, two single-channel devices tDCS model Activodos made in the United States will be used. Active electrodes according to the involved side, is left M1( c3) and DLPFC( F3) or right m1 (c4) and DLPFC ( F4 ) and reference electrodes will be placed on the superorbital of contralateral side. A constant current of 1 mA is applied to the M1 region for 20 minutes. Stimulation in theDorsolateral prefrontal cortex is extinguished with the same intensity after 30 seconds. In order to localize the excitability of the motor cortex, an active electrode of 16 cm2 and a reference electrode of 35 cm2 will be used. No - There is not a plan to make this available Justification or reason for not sharing IPD is Data confidentiality
public Somaye azarnia
Evin
Tehran Iran (Islamic Republic of) 1985713834 71732000 azarnia.pt.82@gmail.com University of social welfare and rehabilitation sciences scientific Somaye azarnia
Evin
Tehran Iran (Islamic Republic of) 1985713834 71732000 azarnia.pt.82@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) First ischemic stroke صاهزا At least 6 months have passed since the stroke MCA stroke Patients using the ashworth Modified Modified Scale (MMAS) to have a wrist flexion muscle spasm severity of 1 or higher Patients without chronic neurological diseases such as Parkinson's, Alzheimer's, schizophrenia, radiculopathy, and musculoskeletal disorders, especially upper extremity movement disorders, diagnosed by a neurologist Ability to communicate verbally with the therapist Do not take drugs that change a person's cognitive status No heart disease and pacemaker, No history of seizures, previous brain surgery Patients without severe cognitive and memory impairment. To determine this, the Persian version of MMSE is used and patients must obtain a minimum score of 23 out of a total of 30 points. no limit no limit Both Hemorrhagic stroke patients Stroke patients with arterial injury other than the middle cerebral artery Patients with lacunar stroke Patients with acute and subacute ischemic stroke I67 Other cerebrovascular diseases Rehabilitation Rehabilitation Intervention group: Anodal stimulation of the M1 and pDLPFC of the involved side. To create electrical brain movements, 2 devices of a tDCS channel, model Activados, made in the USA will be used. Active electrodes according to the involved side, is left M1( c3) and DLPFC( F3) or right m1 (c4) and DLPFC ( F4 ) and reference electrodes will be placed on the contralateral of superorbital . Constant current with an intensity of 1 mA for 20 minutes with active electrode of 16 cm2 and a reference electrode of 35 cm2 will be used. Control group: Real anodal stimulation of the primary motor cortex and sham stimulation of the Dorsolateral prefrontal cortex involved side. To create electrical stimulation of the brain, two single-channel devices tDCS model Activodos made in the United States will be used. Active electrodes according to the involved side, is left M1( c3) and DLPFC( F3) or right m1 (c4) and DLPFC ( F4 ) and reference electrodes will be placed on the superorbital of contralateral side. A constant current of 1 mA is applied to the M1 region for 20 minutes. Stimulation in theDorsolateral prefrontal cortex is extinguished with the same intensity after 30 seconds. In order to localize the excitability of the motor cortex, an active electrode of 16 cm2 and a reference electrode of 35 cm2 will be used. Motor function. Timepoint: Upon entering the study, after the first and last session of stimulation. Method of measurement: Fugl meyer test. Spasticity. Timepoint: Upon entering the study, after the first and last session of stimulation. Method of measurement: Modified Modified Ashworth Scale. University of social welfare and rehabilitation sciences Approved 2021-10-20 Ethics Committee of the University of Rehabilitation Sciences and Social Health Evin Tehran Tehran Iran (Islamic Republic of)