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IRCT20211030052912N2 IRCT 2021-11-13 University of social welfare and rehabilitation sciences The Effect of Unihemispheric Concurrent Dual-Site Transcranial Direct Current Stimulation of Primary Motor and Dorsolateral Prefrontal Cortices on cerebral plasticity (with magnetic resonance spectroscopy) in Patients With chronic Stroke: A double-blind controlled clinical trial The Effect of Unihemispheric Concurrent Dual-Site Transcranial Direct Current Stimulation of Primary Motor and Dorsolateral Prefrontal Cortices on cerebral plasticity (with magnetic resonance spectroscopy) in Patients With chronic Stroke: A double-blind controlled clinical trial 2021-11-29 anticipated 22 Complete https://irct.ir/trial/59661 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done through Randomization.com. In this method, according to the two intervention groups (A) and control (B), 6 blocks of 4 will be determined. 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. 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, Blinding description: In order to protect patients 'personal information, patients' names and the type of study group are entered in a booklet along with a numeric code that has nothing to do with the national code or ID number, and all information in the computer and forms and analyzes are based on that numeric code. And the booklet will only be kept safe by the researcher and out of reach of others, and the information reported in the research will not be such that the identity of patients can be ascertained. At the beginning of the implementation, all patients are informed that they may be in the intervention or control group, but will be unaware of this issue until the end of the project. After extracting the data, if the intervention is effective, the control group will be called and effective intervention for them. In addition to the patients, the person analyzing the MRS results (evaluator) is also unaware. Randomization and intervention will be performed by a person who is not involved in the patient evaluation process. 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. The location of the electrodes is determined using an international system of 10-20 electroencephalographs. The electrode pads are soaked in saline. 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.The electrical stimulation will last for 5 sessions. After stimulating the patient, he will perform routine upper extremity exercises. 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 Azarnia Somaye
No. 10/1, Shahid Nazari St., Shahid Beheshti Blvd., Rasht Blvd.
Rasht Iran (Islamic Republic of) 4145985715 +98 13 3362 1657 azarnia.pt.82@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) First ischemic stroke MCA stroke At least 6 months have passed since the stroke Patients with chronic neurological diseases such as Parkinson's, Alzheimer's, schizophrenia, radiculopathy, and musculoskeletal disorders, especially upper extremity movement disorders, are not diagnosed by a neurologist No history of brain tumor 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 with 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 Lack of patient cooperation for post-intervention tests . People who withdraw from the research for any reason and do not want to continue the research. Severe fatigue so that the person is unable to continue the test Sensitivity of the patient's scalp to stimuluse G46 Vascular syndromes of brain in cerebrovascular diseases Treatment - Other Treatment - Other 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. The location of the electrodes is determined using an international system of 10-20 electroencephalographs. The electrode pads are soaked in saline. 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.The electrical stimulation will last for 5 sessions. After stimulating the patient, he will perform routine upper extremity exercises. 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. Brain metabolite activity. Timepoint: Before and after the first electrical stimulation. Method of measurement: Metabolite content based on PPM with MRI. University of social welfare and rehabilitation sciences Approved 2021-10-20 Ethics Committee of the University of Rehabilitation Sciences and Social Health No. 10/1, Shahid Nazari St., Shahid Beheshti Blvd, Rasht Rasht Guilan Iran (Islamic Republic of)