Protocol summary
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Study aim
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Determining the effectiveness of applying the 3mA TDCS protocol in the right lower frontal and left supraorbital regions on cognitive functions, depression, anxiety, and severity of obsessive-compulsive symptoms in people with OCD
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Design
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A controlled, parallel-group, double-blind, randomized clinical trial on 40 patients. Simple randomization was used.
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Settings and conduct
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This research will be carried out in the Beheshti hospital clinic in Zanjan with direct current transcranial electrical stimulation for 20 sessions in 10 days.
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Participants/Inclusion and exclusion criteria
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Having the full diagnostic criteria for obsessive-compulsive disorder as diagnosed by a psychiatrist and psychologist based on the diagnostic and statistical manual of mental disorders, age range 18 to 50 years, not receiving psychological treatment two months before the intervention, and simultaneously with the implementation of the intervention until the follow-up period, the same Being the drug group used along with adjusting the dose. Inclusion criteria: psychosis, risk of suicide, presence of electrical objects in the body, history of seizures, pregnancy, Comorbid bipolar disorder
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Intervention groups
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According to the desired protocol, the patients of the intervention group will receive real stimulation with an intensity of 3 milliamps for twenty sessions of 20 minutes in ten days, with the anode placed in the right area of the lower frontal cortex and the cathode on the left supraorbital area. And the sham group will also receive sham stimulation for the same number of sessions in these areas.
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Main outcome variables
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Clinical symptoms of obsessive-compulsive disorder, working memory, cognitive inhibition, cognitive flexibility, visual memory, sustained attention, depression, anxiety
General information
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Reason for update
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Increasing the sample size and adding follow-up three months after treatment
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230216057437N1
Registration date:
2023-03-31, 1402/01/11
Registration timing:
prospective
Last update:
2025-03-06, 1403/12/16
Update count:
1
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Registration date
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2023-03-31, 1402/01/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-04-09, 1402/01/20
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Expected recruitment end date
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2023-10-12, 1402/07/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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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
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-02-16, 1401/11/27
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Ethics committee reference number
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IR.ZUMS.REC.1401.339
Health conditions studied
1
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Description of health condition studied
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Obsessive-Compulsive Disorder
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ICD-10 code
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F42
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ICD-10 code description
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Obsessive-compulsive disorder
Primary outcomes
1
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Description
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The person's score on the Yale-Brown Obsessive-Compulsive Scale
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Timepoint
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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
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Method of measurement
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Yale-Brown Obsessive-Compulsive Scale
2
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Description
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Individual's score in Beck depression questionnaire
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Timepoint
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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.
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Method of measurement
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Beck depression inventory
3
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Description
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Individual's score in Beck's anxiety inventory
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Timepoint
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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.
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Method of measurement
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Beck's anxiety inventory
Secondary outcomes
1
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Description
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The score of a person's working memory in the task of Spatial Working Memory (SWM) from Cambridge Neuropsychological Test Automated Battery (CANTAB)
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Timepoint
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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.
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Method of measurement
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the Spatial Working Memory (SWM) task from CANTAB
2
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Description
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A person's cognitive inhibition score in the Stop Signal Task (SST) from CANTAB
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Timepoint
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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.
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Method of measurement
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the Stop Signal Task (SST) from CANTAB
3
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Description
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The score of the person's cognitive flexibility in the Intra-Extra Dimensional Set Shift (IED) task from CANTAB
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Timepoint
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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.
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Method of measurement
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the Intra-Extra Dimensional Set Shift (IED) task from CANTAB
4
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Description
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A person's visual memory score in the Paired Associates Learning assignment from CANTAB
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Timepoint
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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.
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Method of measurement
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the Paired Associates Learning assignment from CANTAB
5
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Description
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The score of a person's sustained attention in the task of Rapid Visual Information Processing from CANTAB
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Timepoint
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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.
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Method of measurement
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the task of Rapid Visual Information Processing from CANTAB
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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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.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zanjan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available