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IRCT20260512069367N1 IRCT 2026-05-17 Shahed University Effectiveness and comparison of transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) on emotion regulation, mood symptoms, and cognitive performance in women with premenstrual syndrome Effectiveness and comparison of transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) on emotion regulation, mood symptoms, and cognitive performance in women with premenstrual syndrome 2026-05-22 anticipated 45 Recruiting https://irct.ir/trial/90033 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, after examining the entry and non-entry conditions, 45 eligible participants are selected by simple randomization using a lottery. Each participant is randomly assigned to one of the groups. This is done again using a lottery. Finally, 3 groups (2 intervention groups and a placebo group) are named using the same lottery method again, Blinding description: Participants do not know which group (there are 2 intervention groups and a placebo group) they are in, and the 2 collaborators who are responsible for evaluating the outcome and analyzing the data are also unaware of which group the individuals are in. N/A Premenstrual syndrome. Intervention 1: Intervention group 1: This group receives tDCS with an electric current of 2 mA for 20 minutes in the dorsolateral prefrontal cortex (DLPFC) for 10 sessions (10 consecutive days) during the luteal phase of the menstrual cycle, with the left side (F3) being the anode and the right side (F4) being the cathode. Intervention 2: Intervention group 2: During the luteal phase of the menstrual cycle, this group receives tACS with an electric current of 2 mA at an alpha frequency of 10 Hz in the DLPFC by placing the active electrode in the F3 area and the reference electrode in the F4 area for 10 sessions (10 consecutive days). Intervention 3: Control group: This group receives sham stimulation for 20 minutes in the DLPFC for 10 sessions (10 consecutive days) during the luteal phase of the menstrual cycle. 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 There is no further information
public Zahra Tavana
Unit 3, No. 3, Naser Alley, Patris Lomomba Ave., Satarkhan Blv
Tehran Iran (Islamic Republic of) 1443654351 +98 21 6642 6288 z.tavanapsy@gmail.com Shahed University scientific Zahra Tavana
Unit 3, No. 3, Naser Alley, Patris Lomomba Ave., Satarkhan Blvd
Tehran Iran (Islamic Republic of) 1443654351 +98 21 6642 6288 z.tavanapsy@gmail.com Shahed University Iran (Islamic Republic of) Iran (Islamic Republic of) Women between the ages of 18 and 45 who have had more than two periods with symptoms of premenstrual syndrome Having regular menstruation 18 years 45 years Female at the moment , taking medication for premenstrual syndrome Prosthesis in the skull area History of brain tumor History of seizures Battery in the heart Clinical disorders such as Major Depression Disorder, Bipolar Disorder, Generalized Anxiety Disorder, Acute Stress Disorder, and Post-Traumatic Stress Disorder Personality Disorder N94.3 Premenstrual tension syndrome Treatment - Devices Treatment - Devices Placebo Intervention group 1: This group receives tDCS with an electric current of 2 mA for 20 minutes in the dorsolateral prefrontal cortex (DLPFC) for 10 sessions (10 consecutive days) during the luteal phase of the menstrual cycle, with the left side (F3) being the anode and the right side (F4) being the cathode. Intervention group 2: During the luteal phase of the menstrual cycle, this group receives tACS with an electric current of 2 mA at an alpha frequency of 10 Hz in the DLPFC by placing the active electrode in the F3 area and the reference electrode in the F4 area for 10 sessions (10 consecutive days). Control group: This group receives sham stimulation for 20 minutes in the DLPFC for 10 sessions (10 consecutive days) during the luteal phase of the menstrual cycle. Emotion regulation score, based on the Difficulties in Emotion Regulation Scale – 16 items(DERS-16). Timepoint: Before starting interventions once in the follicular phase In the luteal phase, once in the first session before the start of the intervention; at the end of the fifth session of the intervention; at the end of the tenth session of the intervention; After the intervention is completed, once in the follicular phase and once in the luteal phase. Method of measurement: Difficulties in Emotion Regulation Scale – 16 items(DERS-16) Bjureberg. Mood symptom score based on the Depression Anxiety Stress Scales - 21(DASS-21). Timepoint: Before starting interventions once in the follicular phase In the luteal phase, once in the first session before the start of the intervention; at the end of the fifth session of the intervention; at the end of the tenth session of the intervention; After the intervention is completed, once in the follicular phase and once in the luteal phase. Method of measurement: Depression Anxiety Stress Scales - 21(DASS-21) Lovibond. Cognitive performance score in attention and response inhibition by the Integrated Visual and Auditory Continuous Performance Test(IVA-2). Timepoint: Before starting interventions once in the follicular phase In the luteal phase, once in the first session before the start of the intervention; at the end of the fifth session of the intervention; at the end of the tenth session of the intervention; After the intervention is completed, once in the follicular phase and once in the luteal phase. Method of measurement: Integrated Visual and Auditory Continuous Performance Test(IVA-2). Shahed University Approved 2026-05-03 Ethics Committee of the Faculty of Medicine, Shahed University opposite the Holy Shrine, Persian Gulf Highway, Tehran Tehran Iran (Islamic Republic of)