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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

Protocol summary

Study aim
Studying the effectiveness and comparison of two methods: direct transcranial electrical stimulation (tDCS) and alternative transcranial electrical stimulation (tACS) on three variables: emotion regulation, mood symptoms, and cognitive function in women with premenstrual syndrome
Design
Controlled clinical trial, with parallel groups, double-blind, randomized; Simple randomization method with sealed envelope device is used for randomization
Settings and conduct
This research will be informed through cyberspace and posters in Tehran and will be conducted at Shahed University, Mostafa Khomeini Hospital, and Varsh Counseling Center In this study, Participants, experimenters, and statisticians were blinded..
Participants/Inclusion and exclusion criteria
Women living in Tehran between the ages of 18 and 45 Have premenstrual syndrome Having regular menstruation Not currently taking medication for premenstrual syndrome No prosthesis in the skull area No history of brain tumor No battery in the heart No history of seizures Absence of clinical disorders such as Major Depression Disorder, Bipolar Disorder, Generalized Anxiety Disorder, Acute Stress Disorder, and Post-Traumatic Stress Disorder Not having a Personality Disorder
Intervention groups
One group received tDCS with an electric current of 2 mA for 20 minutes in the dorsolateral prefrontal cortex (DLPFC) for 10 sessions (10 consecutive days) with the left side (F3) being the anode and the right side (F4) being the cathode One group will receive 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) A sham group
Main outcome variables
Are tDCS and tACS effective and different in improving emotion regulation; mood symptoms; and cognitive function in women with premenstrual syndrome?

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260512069367N1
Registration date: 2026-05-17, 1405/02/27
Registration timing: prospective

Last update: 2026-05-17, 1405/02/27
Update count: 0
Registration date
2026-05-17, 1405/02/27
Registrant information
Name
Zahra Tavana
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 6288
Email address
z.tavanapsy@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
Expected recruitment end date
2026-11-22, 1405/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women between the ages of 18 and 45 who have had more than two periods with symptoms of premenstrual syndrome Having regular menstruation
Exclusion criteria:
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
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Medicine, Shahed University
Street address
opposite the Holy Shrine, Persian Gulf Highway,
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2026-05-03, 1405/02/13
Ethics committee reference number
IR.SHAHED.MED.REC.1405.008

Health conditions studied

1

Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

Primary outcomes

1

Description
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

2

Description
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

3

Description
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)

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Devices

2

Description
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).
Category
Treatment - Devices

3

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahed University
Full name of responsible person
Zahra Tavana
Street address
opposite the Holy Shrine, Persian Gulf Highway,
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5522 8800
Email
z.tavanapsy@gmail.com

2

Recruitment center
Name of recruitment center
Varesh Counseling and Psychology Center
Full name of responsible person
Zahra Tavana
Street address
Unit 2, No. 5, Patris Lomomba Ave., satarkhan Blvd
City
Tehran
Province
Tehran
Postal code
1443633117
Phone
+98 21 6657 3387
Email
z.tavanapsy@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Hamed Sajedi
Street address
Central building, Shahed University, opposite of shrine of Imam Khomeini, Persian Gulf Highway Shrine of Imam Khomeini, khali the shrim ine of Imam Khomeini
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5106
Email
publicrelation@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Zahra Tavana
Position
Student of PHD
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 3, No. 3, Naser Alley, Patris Lomomba Ave., Satarkhan Blv
City
Tehran
Province
Tehran
Postal code
1443654351
Phone
+98 21 6642 6288
Email
z.tavanapsy@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Zahra Tavana
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 3, No. 3, Naser Alley, Patris Lomomba Ave., Satarkhan Blvd
City
Tehran
Province
Tehran
Postal code
1443654351
Phone
+98 21 6642 6288
Email
z.tavanapsy@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Zahra Tavana
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 3, No. 3, Naser Alley, Patris Lomomba Ave, Satarkhan Blvd
City
Tehran
Province
Tehran
Postal code
1443654351
Phone
+98 21 6642 6288
Email
z.tavanapsy@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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