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IRCT20211030052912N3 IRCT 2023-01-28 Rasht University of Medical Sciences Evaluation of the effect of Unihemispheric Concurrent Dual-Site Transcranial Direct Current Stimulation of Dorsolateral Prefrontal Cortex AND primary motor cortex on improvement of lower limb motor function in patients with chronic stroke: A double-blind controlled clinical trial Evaluation of the effect of Unihemispheric Concurrent Dual-Site Transcranial Direct Current Stimulation of Dorsolateral Prefrontal Cortex AND primary motor cortex on improvement of lower limb motor function in patients with chronic stroke: A double-blind controlled clinical trial 2022-12-06 anticipated 37 Complete https://irct.ir/trial/66974 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 DLPFC of the involved side. The two-channel device 2-NEUROSTIM manufactured by Medina Medical Company will be used to create electrical brain movements. The location of the electrodes will be determined using the international 10-20 system of electroencephalography. 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 M1 anal stimulation and sham DLPFC on the involved side. To generate brain electrical stimulations, the 2-NEUROSTIM two-channel device manufactured by Medina Tabgaster Company will be used. The location of the electrodes is determined using the international 10-20 electroencephalography system . The electrode pad is soaked in physiological serum solution. Active electrodes according to the involved side in the areas of the primary motor cortex equivalent to c3 and the posterior-lateral prefrontal cortex equivalent to F3 (in the left involvement) or the primary motor cortex equivalent to c4 and the posterior-lateral prefrontal cortex equivalent to F4 (right involvement) and reference electrodes on They will be placed on the supraorbital of the uninvolved side. A constant current with an intensity of 1 milliampere is applied for 20 minutes in a real way on the c3/c4 area and as a sham on the F3/F4 area. In order to localize the excitability of the motor cortex, the active electrode of 16 cm2 and the reference electrode of 35 cm2 will be used. Electrical stimulation will be for 5 sessions. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of data
public Somaye Azarnia
Guilan University of Medical Sciences' Headquarters, Parastar St., Rasht
Rasht Iran (Islamic Republic of) 13111-41937 +98 13 3334 6489 azarnia.pt.82@gmail.com Rasht University of Medical Sciences scientific Azarnia Somaye
No .10, Shahid Nazari Ave, Shahid Beheshti Blvd., Rasht
Rasht Iran (Islamic Republic of) 4188866449 +98 13 3360 5990 azarnia.pt.82@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) First stroke Medial Cerebellar Artery (MCA) stroke The ability to verbally communicate with the therapist Patients using the Ashworth Modified Modified Scale (MMAS) to have a knee flexion muscle spasm severity of 1 or higher No history of a brain tumor Patients who do not have severe cognitive and memory disorders. To determine this, the Persian version of the Mini-Mental State Examination is used and patients must score at least 23 out of a total of 30 no limit no limit Both Patients with chronic neurological diseases such as Parkinson's, Alzheimer's, schizophrenia, radiculopathy, and musculoskeletal disorders, especially upper extremity movement disorders, diagnosed by a neurologist. History of seizures, previous brain surgery, heart disease and pacemaker Take drugs that change a person's cognitive status G46 Vascular syndromes of brain in cerebrovascular diseases Rehabilitation Rehabilitation Intervention group: Anodal stimulation of the M1 and DLPFC of the involved side. The two-channel device 2-NEUROSTIM manufactured by Medina Medical Company will be used to create electrical brain movements. The location of the electrodes will be determined using the international 10-20 system of electroencephalography. 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 M1 anal stimulation and sham DLPFC on the involved side. To generate brain electrical stimulations, the 2-NEUROSTIM two-channel device manufactured by Medina Tabgaster Company will be used. The location of the electrodes is determined using the international 10-20 electroencephalography system . The electrode pad is soaked in physiological serum solution. Active electrodes according to the involved side in the areas of the primary motor cortex equivalent to c3 and the posterior-lateral prefrontal cortex equivalent to F3 (in the left involvement) or the primary motor cortex equivalent to c4 and the posterior-lateral prefrontal cortex equivalent to F4 (right involvement) and reference electrodes on They will be placed on the supraorbital of the uninvolved side. A constant current with an intensity of 1 milliampere is applied for 20 minutes in a real way on the c3/c4 area and as a sham on the F3/F4 area. In order to localize the excitability of the motor cortex, the active electrode of 16 cm2 and the reference electrode of 35 cm2 will be used. Electrical stimulation will be for 5 sessions. Motor function. Timepoint: Before the first and after last electrical stimulation. Method of measurement: Fugl meyer test. Brain metabolite activity,. Timepoint: Before the first and after last electrical stimulation. Method of measurement: Metabolite content with Magnetic resonance imaging. Rasht University of Medical Sciences Approved 2022-11-09 Ethics Committee of the Guilan University of Medical Sciences Namjoo avenue Rasht Guilan Iran (Islamic Republic of)