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IRCT20210608051514N3 IRCT 2022-05-15 Zanjan University of Medical Sciences Treatment of patients with type 1 bipolar disorder: clinical trial a double-blind study The effectiveness of transcranial direct current stimulation on neurocognition in patients with type 1 bipolar disorder. 2022-06-11 anticipated 60 Complete https://irct.ir/trial/63457 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects are selected from purposive sampling method and using simple randomization method, based on which the subjects are assigned to the two groups of control and experiment by tossing coins.This method is used for two-group clinical trials, according to which one group is called a lion, and the other is called a line, and thus the number of coin samples is tossed, Blinding description: In this study, the clinical evaluator and therapist will be blind to assigning subjects to control and experimental groups. In addition, we use the clinical evaluator separately for baseline assessments and follow-up, and the therapist separately for treatment.Subjects will also be assigned to control groups or blind experiments, so that subjects will not meet outside of the sessions and will visit at times when no other subjects will be present. N/A Condition 1: Bipolar disorder type 1. Condition 2: Bipolar disorder type 1, mania, manic depression, bipolar depression. Intervention 1: Intervention group: Treatment with stimulation of transcranial direct current stimulation with a cintensity of 2 mA for 20 minutes on the lateral dorsal forehead cortex will receive 10 sessions of 20 minutes in 3 consecutive weeks. Intervention 2: Control group: Intervention group: Treatment with stimulation of transcranial direct current stimulation with a cintensity of 2 mA for 40 seconds on the lateral dorsal forehead cortex will receive 10 sessions of 20 minutes in 3 consecutive. Yes - There is a plan to make this available What will be shared: All information of individuals except names and confidential information will be published at the end of the research. Publishable information including: therapeutic changes, results of questionnaires, statistical results of signal analysis, dose and medication used When: The results of this research will be published three months after the end of the research To whom: All researchers, researchers, colleagues, and others Conditions: To carry out similar projects and if all the material and intellectual rights of researchers are observed. Where to obtain: Contact the following email address to receive the documentation: Farahnaz Yousefi Master of Clinical Psychology farahnaz.yosefi76@gmail.com Address: Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province How to obtain: The data will be provided to the applicant after receiving the e-mail of the applicant and observing the material and intellectual rights of the researchers. Comments:
public Omidreza Heidari
Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province
zanjan Iran (Islamic Republic of) 7531974143 +98 21 8670 5698 omid.orh@gmail.com Islamic Azad University scientific Farahnaz Yousefick[hk
Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province
zanjan Iran (Islamic Republic of) 7531974143 02445731 farahnaz.yosefi76@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Having a diagnosis of bipolar disorder type one Being in the euthanic phase based on assessment The same dose and medicine Stabilization in medical treatment for at least 4 weeks Stabilization of drug and medicine dose during research 18 years 65 years Both Having drug use and dependence up to 6 months before treatment Having a history of neurological diseases Having diseases related to the scalp Having a history of head injuries The presence of a device or tool in the head Exclude from the study after absence in two consecutive sessions of treatment Being left-handed اختلال دو F39 Treatment - Other Treatment - Other Intervention group: Treatment with stimulation of transcranial direct current stimulation with a cintensity of 2 mA for 20 minutes on the lateral dorsal forehead cortex will receive 10 sessions of 20 minutes in 3 consecutive weeks. Control group: Intervention group: Treatment with stimulation of transcranial direct current stimulation with a cintensity of 2 mA for 40 seconds on the lateral dorsal forehead cortex will receive 10 sessions of 20 minutes in 3 consecutive Executive performance: Executive performance refers to the ability to integrate thought and action to achieve a goal. Timepoint: pre test_post test_3mounth follow up. Method of measurement: The score that a person gets from the second part of the sequence test. Spatial visual memory: means the ability to store and manipulate information in consciousness for a short period of time. Timepoint: pre test_post test_3mounth follow up. Method of measurement: The score that a person gets from the test of complex images. Delayed Recognition: The ability to retrieve specific information after a period of time or distraction. Timepoint: pre test_post test_3mounth follow up. Method of measurement: The score that a person gets from the test of complex images. Attention is a cognitive process in which the mind focuses on a specific stimulus or stimuli from the environment and other environmental stimuli are ignored. Timepoint: pre test_post test_3mounth follow up. Method of measurement: The score that a person gets from the sequence test in the first part. Zanjan University of Medical Sciences Approved 2022-05-02 Ethics Committee of Zanjan University of Medical Sciences Shahid Beheshti Hospital, Ark Gate, Saadi Crossroads, Zanjan Province zanjan Zanjan Iran (Islamic Republic of)