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IRCT20101130005280N34 IRCT 2020-09-20 Mashhad University of Medical Sciences The effect of transcranial direct current stimulation on cognitive functions in patients with bipolar disorder Investigation of the effect of transcranial direct current stimulation on cognitive functions in patients with bipolar disorder 2020-07-05 anticipated 42 Complete https://irct.ir/trial/50989 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups, Blinding description: Despite the use of electrodes for the whole 20 minutes, for patients in the control group, the electric current is cut off after 30 seconds. This is done to make the patient unaware of the existence of electric current. Also, the investigator is not aware of the presence of electric current. This way, the study will be double-blinded. 2-3 Bipolar disorder. Intervention 1: Intervention group: In this group, the anode is placed in the left prefrontal cortex and the cathode in the right cerebellar region (based on the 10/20 system) at 2 mA for 20 minutes for three consecutive weeks (5 working days). Intervention 2: Control group: In this group, similar to the intervention group, the anode is placed in the left prefrontal cortex and the cathode in the right cerebellar region (based on the 10/20 system) at 2 mA for 20 minutes for three consecutive weeks (5 working days). But the electric current is cut off at second 30.This period of 30 seconds aims to make the patient unaware of whether there is electrical current or not. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data can be accessible through an email to the corresponding author. Conditions: Data will be available for researchers in universities and other scientific institutes. Where to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. How to obtain: Carrying out analysis on data is permitted. Comments:
public Ali Talaei
Ibn Sinal Hospital, Horre Ameli boulevard, Bu Ali Square
Mashhad Iran (Islamic Republic of) 91959 83134 +98 51 3711 2709 talaeia@mums.ac.i Mashhad University of Medical Sciences scientific Dr. Ali Talaei
Ibn Sinal Hospital, Horre Ameli boulevard, Bu Ali Square
Mashhad Iran (Islamic Republic of) 91959 83134 +98 51 3711 2709 talaeia@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with bipolar disorder in the euthymic phase between 18 to 42 years old No being in the manic and depression phase through analyzing the HDRS and YMRS questionnaires Patients must have disorders in several cognitive domains. The patient has no other psychiatric disorder or problem. The patient has not received shock therapy during the past year. 18 years 42 years Both Pregnancy and breastfeeding F31 Bipolar disorder Treatment - Devices Treatment - Devices Intervention group: In this group, the anode is placed in the left prefrontal cortex and the cathode in the right cerebellar region (based on the 10/20 system) at 2 mA for 20 minutes for three consecutive weeks (5 working days) Control group: In this group, similar to the intervention group, the anode is placed in the left prefrontal cortex and the cathode in the right cerebellar region (based on the 10/20 system) at 2 mA for 20 minutes for three consecutive weeks (5 working days). But the electric current is cut off at second 30.This period of 30 seconds aims to make the patient unaware of whether there is electrical current or not. Cognitive functions. Timepoint: At the beginning of the intervention, first, second, third and seventh week. Method of measurement: Stroop test. Attention. Timepoint: At the beginning of the intervention, first, second, third and seventh week. Method of measurement: Digit span test. Memory. Timepoint: At the beginning of the intervention, first, second, third and seventh week. Method of measurement: Rey auditory verbal Learning test and Rey–Osterrieth complex figure. Mashhad University of Medical Sciences Approved 2019-07-02 Ethics Committee of Mashhad University of Medical Sciences Daneshgah street, Ghoreishi building Mashhad Razavi Khorasan Iran (Islamic Republic of)