]>
IRCT20230216057437N1 IRCT 2023-03-31 Zanjan University of Medical Sciences The Effectiveness of 3MA transcranial direct current stimulation (TDCS) on cognitive function, depression, anxiety and severity of obsessive-compulsive symptoms in individuals with OCD: A randomized clinical trial The Effectiveness of 3MA transcranial direct current stimulation (TDCS) on cognitive function, depression, anxiety and severity of obsessive-compulsive symptoms in individuals with OCD: A randomized clinical trial 2023-04-09 anticipated 40 Complete https://irct.ir/trial/68648 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples are randomly assigned to the intervention and sham groups. Random allocation is done using Excel software. For this, in the first column, we enter 20 numbers 1 and 20 numbers 2 representing the real intervention group and the sham intervention group, respectively. Then, in the second column, we generate 40 random numbers using the (RAND) function. We sort the data based on column values containing random numbers (ascending or descending). With this sorting, the order of placement of numbers 1 and 2 will also change and be placed randomly. Based on the order of appearance of numbers 1 and 2, the samples are assigned to two groups, Blinding description: The people under study do not know the type of intervention. Both the researcher and the evaluator are unaware of the type of intervention. The device is set by one of the clinic staff on real or sham intervention and the patient receives a code based on that. The people who analyze the results do not know the nature of the study groups and the evaluation is done by someone other than the researcher. N/A Obsessive-Compulsive Disorder. Intervention 1: Intervention group: Twenty sessions of 20 minutes in ten days under real stimulation with an intensity of 3 milliamperes, with the anode placed on the right area of the inferior frontal cortex and the cathode on the left supraorbital area. Intervention 2: Control group: Twenty sessions of 20 minutes in ten days under sham stimulation with an intensity of 3 milliamperes, with the anode placed on the right area of the inferior frontal cortex and the cathode on the left supraorbital area. 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
public Atefeh Fatehi chenar
Ark Square, Beheshti Hospital
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3301 8100 atefehfatehi993@gmail.com Zanjan University of Medical Sciences scientific Atefeh Fatehi chenar
Ark Gate, Beheshti Hospital
Zanjan Iran (Islamic Republic of) 1578845136 +98 24 3354 4001 atefehfatehi993@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Having complete OCD diagnostic criteria as diagnosed by a psychiatrist and psychologist based on DSM-5 Having at least a third middle school education Age range between 18-50 years Sign the written consent Not receiving psychological treatment two months before the intervention and simultaneously with the implementation of the intervention until the follow-up period The same drug group was used along with dose adjustment 18 years 50 years Both Risk of suicide psychosis Existence a history of seizures and epilepsy The presence of an electrical or metallic object in the body Diagnosis of any neurological conditions that affects the central nervous system. (like Parkinson's) pregnancy Comorbid bipolar disorder F42 Obsessive-compulsive disorder Treatment - Devices Treatment - Devices Intervention group: Twenty sessions of 20 minutes in ten days under real stimulation with an intensity of 3 milliamperes, with the anode placed on the right area of the inferior frontal cortex and the cathode on the left supraorbital area. Control group: Twenty sessions of 20 minutes in ten days under sham stimulation with an intensity of 3 milliamperes, with the anode placed on the right area of the inferior frontal cortex and the cathode on the left supraorbital area. The person's score on the Yale-Brown Obsessive-Compulsive Scale. Timepoint: Measuring the severity of obsessive-compulsive symptoms before the intervention, immediately after the intervention, two weeks, four weeks, and three months after the intervention as follow-up periods. Method of measurement: Yale-Brown Obsessive-Compulsive Scale. Individual's score in Beck depression questionnaire. Timepoint: Measurement of depression levels before the intervention, immediately after the intervention, and two-week, four-week, and three-month follow-up periods after the intervention. Method of measurement: Beck depression inventory. Individual's score in Beck's anxiety inventory. Timepoint: Measurement of anxiety levels before the intervention, immediately after the intervention, and two-week, four-week, and three-month follow-up periods after the intervention. Method of measurement: Beck's anxiety inventory. The score of a person's working memory in the task of Spatial Working Memory (SWM) from Cambridge Neuropsychological Test Automated Battery (CANTAB). Timepoint: Measuring the individual's score in the task of Spatial Working Memory (SWM) before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods. Method of measurement: the Spatial Working Memory (SWM) task from CANTAB. A person's cognitive inhibition score in the Stop Signal Task (SST) from CANTAB. Timepoint: Measuring the individual's score in the Stop Signal Task (SST) task before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods. Method of measurement: the Stop Signal Task (SST) from CANTAB. The score of the person's cognitive flexibility in the Intra-Extra Dimensional Set Shift (IED) task from CANTAB. Timepoint: Measuring the individual's score in the Intra-Extra Dimensional Set Shift (IED) task before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods. Method of measurement: the Intra-Extra Dimensional Set Shift (IED) task from CANTAB. A person's visual memory score in the Paired Associates Learning assignment from CANTAB. Timepoint: Measuring the individual's score in the Paired Associates Learning task before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods. Method of measurement: the Paired Associates Learning assignment from CANTAB. The score of a person's sustained attention in the task of Rapid Visual Information Processing from CANTAB. Timepoint: Measuring the individual's score in the Rapid Visual Information Processing task before the intervention, Immediately after the end of the intervention, two weeks, four weeks, and three months after the end of the intervention as follow-up periods. Method of measurement: the task of Rapid Visual Information Processing from CANTAB. Zanjan University of Medical Sciences Approved 2023-02-16 Ethnics committee of Zanjan University of Medical Sciences Zanjan University of Medical Sciences , Mahdavi Blv, shahrak karmandan Zanjan Zanjan Iran (Islamic Republic of)