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IRCT20191208045665N2 IRCT 2023-01-11 Tarbiat Modares University The effect of transcranial electrical stimulation on brain tumor growth and depression caused by it trial Investigation the effect of transcranial electrical stimulation on GBM tumor growthand depression 2023-01-21 anticipated 54 Complete https://irct.ir/trial/67881 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with a sealed previously prepared envelope. N/A Glioblastoma Brain Tumor. Intervention 1: First intervention group: Simultaneously under the standard treatment of chemotherapy and alternating electric current - ). Intermittent tECS is used where the glioblastoma brain tumor is located with a maximum current of 2 milliamps and a maximum voltage of 18 volts (during 20 consecutive sessions of 12 hours). They receive standard chemotherapy treatment according to the treatment protocol. Intervention 2: Second intervention group: Simultaneously under the standard treatment of chemotherapy and alternating electric current of virtual feedback - ). Intermittent tECS is used where the glioblastoma brain tumor is located without applying electrical stimulation (during 20 consecutive sessions of 12 hours). They receive standard chemotherapy treatment according to the treatment protocol. Intervention 3: Control group: Simultaneously under standard chemotherapy treatment. They receive standard chemotherapy treatment according to the treatment protocol. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Mohammad Rostami
Simulator Systems Laboratory - Faculty of Electrical Engineering - Tarbiat Modares University- Nasr Bridge
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 3904 M-Rostami@modares.ac.ir Tarbiat Modares University scientific Mohammad Rostami
Simulator Systems Laboratory - Nasr Bridge - Faculty of Electrical Engineering - Tarbiat Modares University
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 3904 M-Rostami@modares.ac.ir Tarbiat Modarres University Iran (Islamic Republic of) Age between 10-75 years old Patients with recurrent Glioblastoma Brain tumor 10 years 75 years Both People with systemic diseases Patient's non-cooperation C71.9 Malignant neoplasm of brain, unspecified Treatment - Other Treatment - Other Treatment - Other First intervention group: Simultaneously under the standard treatment of chemotherapy and alternating electric current - ). Intermittent tECS is used where the glioblastoma brain tumor is located with a maximum current of 2 milliamps and a maximum voltage of 18 volts (during 20 consecutive sessions of 12 hours). They receive standard chemotherapy treatment according to the treatment protocol. Second intervention group: Simultaneously under the standard treatment of chemotherapy and alternating electric current of virtual feedback - ). Intermittent tECS is used where the glioblastoma brain tumor is located without applying electrical stimulation (during 20 consecutive sessions of 12 hours). They receive standard chemotherapy treatment according to the treatment protocol. Control group: Simultaneously under standard chemotherapy treatment. They receive standard chemotherapy treatment according to the treatment protocol. Depression score in Hamilton questionnaire. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (45 days after the start of the intervention). Method of measurement: Depression Hamilton Scale. Tumor size in MRI with contrast. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (45 days after the start of the intervention). Method of measurement: MRI imaging. Depression score in Beck questionnaire. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (45 days after the start of the intervention). Method of measurement: Beck Depression Inventory. Mohammad Rostami Approved 2022-12-28 Research Ethics Committees of Iran University of Medical Sciences Simulation Systems Laboratory, Faculty of Electrical Engineering, Tarbiat Modares University, Nasr Bridge, Tehran Tehran Tehran Iran (Islamic Republic of)