]>
IRCT20210517051330N1 IRCT 2021-06-20 Zanjan University of Medical Sciences Comparison of the effectiveness of traditional transcranial stimulation with multichannel extracranial stimulation on improving the clinical symptoms of people with major depression and improving their executive function Optimization of transcranial stimulation protocol with direct flow on executive functions and reduction of symptoms in people with major depression 2021-06-22 anticipated 60 Complete https://irct.ir/trial/56599 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple randomization Randomization unit: individual Randomization tool: Random number table How to make: First, the list of names of all members is obtained, then a score or number is assigned to each of them, and the required number is selected using a table of random numbers. Hiding: Using sealed envelopes in random order, Blinding description: The subjects do not know the type of intervention. The patient receives the intervention in separate coded treatment rooms. No mirrors are installed on the patient's entrance and exit. Coding is done by one of the design partners. Patients do not see each other during the intervention. People who analyze the results do not know the nature of the study groups. The evaluation is done by someone other than the researcher. N/A Major Depression. Intervention 1: Intervention group 1: Traditional transcranial stimulation, in the treatment of direct current stimulation from the skull, two electrodes, one positive pole and the other negative pole, are placed on the head through a sponge pad soaked in conductive solution. Electric current by these electrodes reaches the surface of the cerebral cortex after passing through different areas (scalp, skull). The current that reaches this area charges the neurons with electricity and causes a positive and a negative pole, which leads to a change in the activity of that area. Intervention 2: Intervention group: Intervention group: Group 2: Multichannel transcranial stimulation: Similar to the traditional method, except that smaller electrodes are used to stimulate networks and not just brain areas. Star Stim device is a combined electrical stimulation device with tape It is a brain that has 8 channels. This device has a cap that has designed 39 positions based on the 10-10 system to place the electrodes on the head. The electrodes include dry and wet gel carriers for electroencephalography, electrodes in different sizes for stimulation and combined electrodes, as well as reference electrodes. The software is related to this NIC device, which allows us to do so. Let us have an anodal study and also be able to include the sham group or the double-blind method in our studies.In this study, the stimulation is for 20 sessions of 30 minutes. Intervention 3: Control group: Control group: A method to reduce bias in clinical trials that use brain stimulation therapies such as the traditional transcranial stimulation method. It is based on imitation of the same main treatment. Its duration is 30 minutes in the form of 30 seconds of ramp-up, 30 seconds of stimulation, 30 seconds of ramp down. Yes - There is a plan to make this available What will be shared: Outcomes and results are published in the form of statistics When: After publishing the article To whom: The data will be available to researchers Conditions: Can be used for secondary studies Where to obtain: marziehabdi@zums.ac.ir 09224863706 How to obtain: Will be sent after receiving the email Comments: :
public Marzieh Abdi
Ark Square. Shahid Beheshti Hospital
Zanjan Iran (Islamic Republic of) 45136-15788 +98 922 486 3706 Marziehabdi@zums.ac.ir Zanjan University of Medical Sciences scientific Marzieh Abdi
Ark Square. Shahid Beheshti Hospital
Zanjan Iran (Islamic Republic of) 45136-15788 +98 24 3354 4001 Marziehabdi@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Having diagnostic criteria for unipolar MDD based on psychiatrist diagnosis and clinical interview Age range between 75-18 years Failure to treat with at least one antidepressant Do not take antidepressants now or have a consistent medication regimen for the past 4 weeks Score 17 on the Hamilton Depression Inventory Willingness to participate in research Conscious consent to participate in research Have the opportunity to participate in evaluation and treatment sessions (daily) (in terms of distance, cost, etc.) 18 years 75 years Both Diagnosis of bipolar disorder Diagnosis of substance use or alcohol Detection of dementia Diagnosis of personality disorder Diagnosis of brain injury, stroke or brain tumor Existence or history of psychosis Diagnosis of epilepsy or history of loss of consciousness Pregnancy Contraindications to the use of tDCS (cranial plates), such as those using a pacemaker. Currently or in the last 4 weeks the person has received another treatment for MDD (medication or other psychological treatments) Having diseases related to the scalp Having a history of head trauma and the presence of a device or tools in the head F32.9 Major depressive disorder, single episode, unspecified Treatment - Devices Treatment - Devices Treatment - Devices Intervention group 1: Traditional transcranial stimulation, in the treatment of direct current stimulation from the skull, two electrodes, one positive pole and the other negative pole, are placed on the head through a sponge pad soaked in conductive solution. Electric current by these electrodes reaches the surface of the cerebral cortex after passing through different areas (scalp, skull). The current that reaches this area charges the neurons with electricity and causes a positive and a negative pole, which leads to a change in the activity of that area. Intervention group: Intervention group: Group 2: Multichannel transcranial stimulation: Similar to the traditional method, except that smaller electrodes are used to stimulate networks and not just brain areas. Star Stim device is a combined electrical stimulation device with tape It is a brain that has 8 channels. This device has a cap that has designed 39 positions based on the 10-10 system to place the electrodes on the head. The electrodes include dry and wet gel carriers for electroencephalography, electrodes in different sizes for stimulation and combined electrodes, as well as reference electrodes. The software is related to this NIC device, which allows us to do so. Let us have an anodal study and also be able to include the sham group or the double-blind method in our studies.In this study, the stimulation is for 20 sessions of 30 minutes. Control group: Control group: A method to reduce bias in clinical trials that use brain stimulation therapies such as the traditional transcranial stimulation method. It is based on imitation of the same main treatment. Its duration is 30 minutes in the form of 30 seconds of ramp-up, 30 seconds of stimulation, 30 seconds of ramp down. Percentage of people whose Beck questionnaire score is above 20. Timepoint: Measurement of depression before the intervention, in the tenth session of the intervention, after the intervention, one-month follow-up and three months after the intervention. Method of measurement: Beck Questionnaire. Percentage of people whose Hamilton questionnaire score is above 17. Timepoint: Measurement before intervention, after the intervention, one-month follow-up and three months after the intervention. Method of measurement: Hamilton Depression Test. Depression Score on the Montgomery–Åsberg Depression Rating Scale. Timepoint: Measurements before the intervention, after the intervention.one-month follow-up and three months after the intervention. Method of measurement: Montgomery–Åsberg Depression Rating Scale. Cognitive test score in cantab test. Timepoint: Measurements before the intervention, after the intervention.one-month follow-up and three months after the intervention. Method of measurement: cantab test. Analyze the electroencephalography results. Timepoint: Measurements before the intervention, after the intervention. Method of measurement: Electroencephalography. Zanjan University of Medical Sciences Approved 2021-05-25 Ethics Committee of Zanjan University of Medical Sciences Azadegan Square Zanjan Zanjan Iran (Islamic Republic of)