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IRCT20220321054335N1 IRCT 2022-10-29 Atieh Clinical Neuroscience Center (ACNC) Effect of rTMS with and without CCR in treatment of the bipolar disorder Comparison of the effectiveness of transcranial magnetic stimulation (TMS) therapy with and without computer-based cognitive rehabilitation (CCR) in the brain signal of patients with bipolar disorder 2022-09-06 anticipated 30 Complete https://irct.ir/trial/65283 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Blinding description: In this study,psychologists (evaluators), technicians, therapists (Health care personnel), and psychometricians will be blinded to the research design. In other words, the people referred to the evaluator or for treatment will be completely unaware that this person is part of a research project or a regular clinic patient. N/A Bipolar Disorder. Intervention 1: Intervention group: Bilateral rTMS; The coil will locate on F3 and F4 in accordance with the 10-20 international system. Bilateral rTMS include stimulate the right DLPFC at 1 Hz for a 10 seconds train of stimulation, and a total of 900 pulse trains. Immediately after that, the stimulation was carried out on the left DLPFC at 10 Hz, 5 seconds of stimulation, with 10 second inter-train interval and 75 pulse trains. Intervention 2: Intervention group: Bilateral rTMS with Cognitive rehabilitation therapy; In this group, the same TMS protocol as the first group will be used, and after a short break from the end of the TMS session, they will receive attention and memory exercises according to their level in about 45 minutes for 14 sessions using Rahacom rehabilitation software. Yes - There is a plan to make this available What will be shared: All the initial and final evaluations of the treatment will be stored in Excel without the names of the participants. When: After the end of the study and the analysis of the results and the publication of the preliminary results (assuming about 6 months after the end of the study), it will be possible to request access to the data. To whom: Researchers in line with the research topic without restrictions Conditions: In order to improve the treatment and the scientific field in question, all researchers can apply with a guarantee of trustworthiness. Where to obtain: ahmadi.hanie@gmail.com How to obtain: In the form of an email, the type of data and documents expected and the reason for the request will be sent, and the researcher will send the information format. Comments:
public Reza Rostami
No. 23, Vali Nejad St., above Vanak Square, Valiasr St., Tehran
Tehran Iran (Islamic Republic of) 3169467471 +98 21 8401 2000 rezaros@gmail.com University of Tehran scientific Haniyeh Ahmadi Segazi
No. 628, Khazaei Alley, Shahid Sadoughi Street, Mallard Road, Tehran
Tehran Iran (Islamic Republic of) 3169467471 +98 21 6519 7187 ahmadi.hanie123@gmail.com Atieh Clinical Neuroscience Center (ACNC) Iran (Islamic Republic of) All adults diagnosed with bipolar disorder by psychologists and psychiatrists Minimum education in reading and writing 18 years no limit Both History of epilepsy or convulsions in the person or first degree relatives Having acute heart disease No history of drug use and head trauma Pregnant or breastfeeding women The presence of intracranial implants (such as shunts, electrodes) or any other metal object in or near the head (such as the mouth) Having a pacemaker F31 Bipolar disorder Treatment - Other Treatment - Other Intervention group: Bilateral rTMS; The coil will locate on F3 and F4 in accordance with the 10-20 international system. Bilateral rTMS include stimulate the right DLPFC at 1 Hz for a 10 seconds train of stimulation, and a total of 900 pulse trains. Immediately after that, the stimulation was carried out on the left DLPFC at 10 Hz, 5 seconds of stimulation, with 10 second inter-train interval and 75 pulse trains Intervention group: Bilateral rTMS with Cognitive rehabilitation therapy; In this group, the same TMS protocol as the first group will be used, and after a short break from the end of the TMS session, they will receive attention and memory exercises according to their level in about 45 minutes for 14 sessions using Rahacom rehabilitation software. The score of Bipolar Depression Rating Scale (BDRS). Timepoint: Evaluation of mood symptoms before the start of the intervention and after the last session of TMS and CCR treatment. Method of measurement: Bipolar Depression Rating Scale (BDRS). Evaluation of cognitive functions by Cantab. Timepoint: Evaluation of cognitive functions before the start of the intervention and after the last session of TMS and CCR treatment. Method of measurement: the Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used. Power of frequency bands in rest condition and changes of P300 component during Go-NoGo task (using Mitsar EEG recording device). Timepoint: Evaluation of brain signal before the start of the intervention and after the last session of TMS and CCR treatment. Method of measurement: by 19-channel EEG device during rest and Go-NoGo task. Atieh Clinical Neuroscience Center (ACNC) Approved 2022-05-11 Research Ethics Committees of Faculty of Psychology and Education Dr. Kardan St., in front of Nasr Koi, Faculty of Psychology, University of Tehran Tehran Tehran Iran (Islamic Republic of)