]>
IRCT20220816055725N1 IRCT 2022-10-04 Zanjan University of Medical Sciences Evaluating the effectiveness of transcranial direct current stimulation(tDCS) and oxytocin in food addicts. Evaluating the effectiveness of transcranial direct current stimulation(tDCS) and oxytocin on cognitive, emotion and weight control in food addicts: A double-blind Randomized clinical trial. 2022-09-21 anticipated 45 Complete https://irct.ir/trial/65322 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All the participants were completely randomized in a 6-block classification type (due to the allocation of at least three groups and the parallelism of the design and to control the gender variable), the randomization sequence was created using Stata 9.0 statistical software (StataCorp, College Station, TX). and will be classified using block sizes of 6 with 1:1 allocation and three groups will be formed. Then the treatment plan will be implemented. During the intervention, in order to maintain the allocation concealment mechanism, containers with consecutive numbering will be pre-packed and will have the same appearance. And waxed and stapled will be hidden. Aluminum foil is used inside the envelope so that the envelope is impervious to strong light. In order to prevent confusion in the order of allocation, the participant's name and date of birth are written on the envelope and a video tape is recorded of the sealed envelope with the participant's information. Block randomization will be performed by a list of computer-generated random numbers prepared by an investigator with no clinical involvement in the trial, Blinding description: Blinding of researcher and participant: The drugs are presented to the participants in a completely similar container and coded by the design partners, the participants and the partner who applies the drug have no knowledge about the contents of the drug, the intervening partner in the application of TDCS at the defined hours. will apply the intervention method and has no knowledge about the division of the group. 2 Food addicts. The first group will receive transcranial direct current stimulation (tDCS) for 10 20-minute sessions, five consecutive sessions and five sessions every other day, and at the same time, they will receive oxytocin in the form of a placebo (sodium chloride) in the amount of 40 daily units. (to reduce the placebo effect). The second group will receive oxytocin through intranasal spray in the amount of 40 units daily for 10 days, and at the same time transcranial direct current stimulation (tDCS) in sham for 10 sessions of 20 minutes in five consecutive sessions and They will receive five sessions every other day.The third intervention group will receive transcranial direct current stimulation (tDCS) for 10 sessions and oxytocin (OXT) in the amount of 40 units daily for 10 days. 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 After the completion of the research, a decision will be made about the publication of the data
public Ehsan Saboori
Department of Addiction Studies, Shahid Dr. Beheshti Hospital, Darvazeh Ark
Zanjan Iran (Islamic Republic of) 4515613191 +98 45 3351 0859 saboory@zums.ac Zanjan University of Medical Sciences scientific Ehsan Saboory
Department of Addiction Studies, Shahid Dr. Beheshti Hospital, Darvazeh Ark
Zanjan Iran (Islamic Republic of) 4515613191 +98 45 3351 0859 saboory@zums.ac Zanjan University of Medical Sciences Iran (Islamic Republic of) Female or male participants aged 20 to 65 years and BMI>30 who are obese by the relevant tests and body mass measurement and will be identified "food addiction" based on the food addiction questionnaire (YFAS). Not having significant illnesses including diabetes, malignancy (any cancer or tumor diagnosed by a medical professional), heart disease, uncontrolled blood pressure, psychiatric illness (based on whether they had previously been diagnosed with a mental illness, not having symptoms of psychotic spectrum and bipolar disorder, Alzheimer and dementia), previous head injury that led to a loss of brain function or the presence of any metal in the head area due to injury or surgery that interfered with the results of brain waves or the use of TDCS slowness or any other significant medical condition will be excluded from the study. Obese participants had not received any obesity intervention at the time of data collection. Having minimum literacy to fill out self-report forms means minimum literacy of 9th grade. 18 years 65 years Both Oxytocin sensitivity, non-cooperation, emergency occurrence, being pregnant or being pregnant during the study. F50 Eating disorders Treatment - Drugs The first group will receive transcranial direct current stimulation (tDCS) for 10 20-minute sessions, five consecutive sessions and five sessions every other day, and at the same time, they will receive oxytocin in the form of a placebo (sodium chloride) in the amount of 40 daily units. (to reduce the placebo effect). The second group will receive oxytocin through intranasal spray in the amount of 40 units daily for 10 days, and at the same time transcranial direct current stimulation (tDCS) in sham for 10 sessions of 20 minutes in five consecutive sessions and They will receive five sessions every other day.The third intervention group will receive transcranial direct current stimulation (tDCS) for 10 sessions and oxytocin (OXT) in the amount of 40 units daily for 10 days Cognitive function. Timepoint: Before and after receiving oxytocin and of transcranial direct current stimulation. Method of measurement: By go/no go test and dot probe task. Emotional performance. Timepoint: Before and after receiving oxytocin and transcranial direct current stimulation(tDCS). Method of measurement: By Gross and John emotion regulation questionnaire. Weight control. Timepoint: Before and after receiving oxytocin and transcranial direct current stimulation(tDCS). Method of measurement: By BMI table and scales. Craving for food. Timepoint: Before and after receiving oxytocin and transcranial direct current stimulation(tDCS). Method of measurement: Food craving questionnaire-trait. Food addiction. Timepoint: Before and after receiving oxytocin and transcranial direct current stimulation(tDCS). Method of measurement: Yale Food Addiction Scale. Zanjan University of Medical Sciences Approved 2022-08-02 Ethics Committee of Zanjan University of Medical Sciences Technology Vice-Chancellor, Zanjan University of Medical Sciences, Gavazang road Zanjan Zanjan Iran (Islamic Republic of)