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IRCT20190917044793N2 IRCT 2022-01-15 Ardabil University of Medical Sciences Direct electrical stimulation of the brain in obsessive-compulsive disorder Efficacy of transcranial direct stimulation on amplifation of neuropsychological function in patient with obsessive-compulsive disorder: A double-blind randomize clinical trial with the control group 2022-02-09 anticipated 40 Complete https://irct.ir/trial/61181 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the Restricted Randomization method of block randomization and in each phase, we will have 4 blocks. Generation of random sequences via the blocking method will be done by Random Allocation software. To conceal, we use Allocation Concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Also, non-transparent envelopes sealed with random sequences will be used, that in this method each random sequence is recorded on a card and the cards are placed in the envelope in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration, according to the order of entry of the eligible participants, one of the envelopes will be opened in order and the assigned group of the participant will be revealed, Blinding description: The executive specialist of electrical brain stimulation will be aware of the research topic and will perform therapeutic interventions. He codes the patients and refers them to a psychologist to check the patient's mental state and record the relevant criteria based on the same code. The patients will be tested in the same condition in the Neurotherapy room and the electrodes of the device will be connected to them, but they will not be aware of the type of stimulation. The experimenter who assesses outcome measures will be independent from the one who applied intervention and will be blind to stimulation condition. This method of double-blinding is based on previous works in the field of transcranial electrical stimulation (Gandinga et al., 2006). Accordingly, this study will be a double-blind study. N/A Obsessive-compulsive disorder. Intervention 1: Intervention group: in this group, participants will receive supraorbital left cathodal-cortex and frontal inferior right anodal tDCS stimulation for 20 sessions of 20 minutes in 10 days (two sessions per day at 20-minute intervals) with an intensity of 1.5 mA . Intervention 2: Control group: in this group, participants receive sham electrical stimulation with the sameactual stimulation protocol for 20 seations in 10 days, while the current generator increases the current to 1.5 mA in 30 seconds, and then gradually over a period of 30 seconds, the current reaches zero. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of the participant's personal characteristics
public Dr. Anita Azarkolah
Department of Psychiatry, Fatemi Hospital, Sareyn station, Ardabil
Ardabil Iran (Islamic Republic of) 5614733775 +98 45 3323 2520 dra.azarkolah@gmail.com Ardabil University of Medical Sciences scientific Mohammad Ali Salehinejad
Institute of Cognitive and Brain Sciences, Shahid Beheshti University, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 198396411 +98 21 2243 1616 salehinejadmohammadali@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosis ofobsessive-compulsive disorder based on DSM V Age: 18-50 years old Required written informed consent signed by patients' guardian 18 years 50 years Both History of neurological diseases such as seizures, strokes, or cerebrovascular diseases The existence of metal implants in the body Pregnancy F42 Obsessive-compulsive disorder Treatment - Devices Placebo Intervention group: in this group, participants will receive supraorbital left cathodal-cortex and frontal inferior right anodal tDCS stimulation for 20 sessions of 20 minutes in 10 days (two sessions per day at 20-minute intervals) with an intensity of 1.5 mA . Control group: in this group, participants receive sham electrical stimulation with the sameactual stimulation protocol for 20 seations in 10 days, while the current generator increases the current to 1.5 mA in 30 seconds, and then gradually over a period of 30 seconds, the current reaches zero. Neuropsychological function. Timepoint: Before intervention (baseline 1, 2). after the intervention.14, 30 and 90 days after the intervention. Method of measurement: Cambridge Neuropsychological Test Automated Battery (CANTAB). Working memory. Timepoint: Before intervention (baseline 1, 2). after the intervention.14, 30 and 90 days after the intervention. Method of measurement: Cambridge Neuropsychological Test Automated Battery (CANTAB). Inhibition response. Timepoint: Before intervention (baseline 1, 2). after the intervention.14, 30 and 90 days after the intervention. Method of measurement: Cambridge Neuropsychological Test Automated Battery (CANTAB). Cognitive flexibility. Timepoint: Before intervention (baseline 1, 2). after the intervention.14, 30 and 90 days after the intervention. Method of measurement: Cambridge Neuropsychological Test Automated Battery (CANTAB). Executive functions. Timepoint: Before intervention (baseline 1, 2). after the intervention.14, 30 and 90 days after the intervention. Method of measurement: Test Wisconsin Cards. Severity of obsessive-compulsive symptoms. Timepoint: Before intervention (baseline 1, 2). after the intervention.14, 30 and 90 days after the intervention. Method of measurement: Maudsley Obsessional-Compulsive Inventory. Evaluation of anxiety symptoms. Timepoint: Before intervention (baseline 1, 2). after the intervention.14, 30 and 90 days after the intervention. Method of measurement: Beck Anxiety Inventory (BDI). Ardabil University of Medical Science Approved 2021-05-17 Ethics Committee of Ardabil University of Medical Sciences End of University Street, Ardabil University of Medical Sciences Ardabil Ardabil Iran (Islamic Republic of)