]>
IRCT20230603058374N1 IRCT 2023-06-07 Shiraz University of Medical Sciences The effect of electrical stimulation of the brain on the treatment of obsession TACS_ OCD The Effect of Transcranial Alternating Current Stimulation (TACS) on the Symptoms of Patients with Obsessive-Compulsive Disorder (OCD): a double blind randomized clinical trial 2023-06-15 anticipated 30 Complete https://irct.ir/trial/70481 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The study will be conducted as a double-blind randomized clinical trial, which will have two intervention and control arms. The entered people will be randomly assigned to one of the groups, and the number of members of the groups will be 15 people in each group, one group will actively receive electrical stimulation, and the other group will not receive this stimulation, and for Removing the psychological effect on the control patients, on the same day, the electrical device is placed on the head, but no stimulation takes place (Sham tACS), Randomization description: We use block randomization to generate sequences, which is a common technique in clinical trial design to reduce bias and achieve balance in assigning participants to treatment arms, especially when the sample size is small and the intervention and control groups are similar. The face is filled with participants almost simultaneously and completely randomly. For this purpose, 5 blocks of 6 (according to the sample size which is 30 people) have been considered. Blocking is done using plan software. The concealment stage is done by using sealed opaque envelopes in such a way that the created sequence is placed in the envelopes and given to the expert who is responsible for the electrical stimulation on the day of the experiment, Blinding description: This study will be double-blind, that is, the expert who performs the randomization process will place the patients in two intervention and control groups, and the researcher does not know which group each person is in. Also, Patients are also not given information about which group they are in. Other people, including the personnel of the hospital research center (place of intervention) and the patient's companions, do not know which group each person is in. N/A Obsessive Compulsive Disorder. Intervention 1: Intervention group: Transcranial Alternating Current Stimulation will be performed in 4 weeks, 2 days a week for 20 minutes with a frequency of 40 Hertz and a current of 2 milliamps. Electric current will be applied through conductive rubber electrodes. These electrodes are placed in sponge pads (5 x 7 cm2) soaked with 9% sodium chloride solution to increase the conductivity of the electric current and prevent the increase in temperature. Transcranial alternating current is simultaneously applied bilaterally. Electrodes are placed over the DMPFC (Dorsomedial Prefrontal Cortex) area (F3 and F4, according to the 10-20 system) to induce gamma activity. Intervention 2: Control group: It will receive a sham stimulation for 30 seconds instead of a real electric current. 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 We postponed the detailed planning in this case to the time after the progress of the research implementation.
public Elmira Zeinoddini meymand
7134686499, Ladbastan Dormitory (Next to the Electricity Department), Moadel Gharbi Ave, Mollasadra St
Shiraz Iran (Islamic Republic of) 7134686499 +98 992 874 7955 elmira.meymand@gmail.com Islamic Azad University scientific Elmira Zeinoddini meymand
7134686499, Ladbastan Dormitory (Next to the Electricity Department), Moadel Gharbi Ave, Mollasadra St
Shiraz Iran (Islamic Republic of) 7134686499 +98 992 874 7955 elmira.meymand@gmail.com Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) According to the DSM-5 diagnostic and statistical manual of obsessive-compulsive disorder Age between 18 and 60 years Obtaining a score of 16 (patients with severe and moderate disease conditions) on the Yale Brown scale Absence of other psychiatric and neurological diseases Ability to perform behavioral tests and answer questionnaires by the patient Signing a written consent form by the patient 18 years 60 years Both Inconsistency with study inclusion criteria Patient's unwillingness to participate in the study Patient's inability to perform diagnostic tests Inability to receive tACS due to metal implants, or history of seizures, or history of trauma to the head, or history of neurosurgery Participants who have anasthenia gravis, a pacemaker, a mechanical heart valve, a mechanical implant such as an aneurysm clip, a hip replacement, or any other piece of metal accidentally inserted into their body Any current significant medical condition Serious risk of suicide A female subject who is pregnant or of childbearing potential, sexually active, not using reliable contraception, or breastfeeding Treatment - Other Treatment - Other Intervention group: Transcranial Alternating Current Stimulation will be performed in 4 weeks, 2 days a week for 20 minutes with a frequency of 40 Hertz and a current of 2 milliamps. Electric current will be applied through conductive rubber electrodes. These electrodes are placed in sponge pads (5 x 7 cm2) soaked with 9% sodium chloride solution to increase the conductivity of the electric current and prevent the increase in temperature. Transcranial alternating current is simultaneously applied bilaterally. Electrodes are placed over the DMPFC (Dorsomedial Prefrontal Cortex) area (F3 and F4, according to the 10-20 system) to induce gamma activity. Control group: It will receive a sham stimulation for 30 seconds instead of a real electric current. Obsessive-compulsive symptom score in the Yale Brown Questionnaire. Timepoint: Examining the amount of obsession compulsive symptoms before starting the study and at the end of the first, second and third weeks and Also, at the end of the intervention (end of the fourth week). Method of measurement: Yale Brown Questionnaire:It was created by "Wayne K. Goodman" and his colleagues in 1989 in the United States. Yale Brown Obsessive Compulsive Psychology Test (YBOCS) is the most reliable theoretical test for diagnosing obsessive compulsive disorder in adults, which is used in counseling and psychology centers. This test is a self-report tool to measure obsessive thoughts and obsessive/compulsive behaviors. This questionnaire has 10 statements with a Likert scoring system (from 0 none to 4 very severe), of which 5 options are intended to evaluate obsessive thoughts and 5 other options are considered to evaluate practical obsessions. The two subscales in this questionnaire are: (a) "Obsessive thoughts": including aggressive obsessions, consuming obsessions, sexual obsessions, hoarding or collecting obsessions, religious obsessions, symmetry and order obsessions, miscellaneous obsessions, and physical obsessions, and (b) "Compulsions": including washing and cleaning, checking, repetition rituals, obsessive behaviors related to counting, order and order, hoarding , and various obsessive behaviors. This test can be performed individually or in groups for people 14 years old and above. On average, this test takes about 10 minutes to complete. Beck depression questionnaire score. Timepoint: Checking the level of depression before the study and at the end of the first, second, third and fourth weeks (the end of the study). Method of measurement: Beck Depression Questionnaire:The Beck Depression Questionnaire was first compiled by Beck et al. in 1961. It was revised in 1971 and published in 1978.In general, the content of this questionnaire is the semiotics of depression, but it emphasizes more on the cognitive content. This questionnaire is a type of self-assessment test and can be completed in five to ten minutes. The test items consist of a total of 21 items that are related to different symptoms. The subjects must answer it on a four-point scale from zero to three. Areas such as sadness, pessimism, feelings of helplessness and failure, feelings of guilt, sleep disturbance, loss of appetite, self-loathing, etc. constitute substances. In this way, 2 items are related to affection, 11 items are related to cognition, 2 items are related to obvious behaviors. 5 items are related to physical symptoms and 1 item is related to interpersonal semiotics. Accordingly, this scale determines different degrees of depression from mild to very severe, and its scores range from a minimum of 0 to a maximum of 63. Shiraz University of Medical Sciences Approved 2023-05-21 Research Ethics Committee of Shiraz University of Medical Sciences Central Building of Shiraz University of Medical Sciences, Karimkhan Zand Blvd Shiraz Fars Iran (Islamic Republic of)