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IRCT20221230056984N1 IRCT 2023-06-08 Zahedan University of Medical Sciences Comparison of the Influence of tDCS and tACS Treatment on Pain Perception and Severity of Symptoms in Patients with Migraine Comparison of the Influence of tDCS and tACS Noninvasive Brain Stimulation Treatments on Pain Perception and Severity of Symptoms in Patients with Migraine 2023-06-20 anticipated 45 Complete https://irct.ir/trial/67713 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Clients receiving a diagnosis of migraine from internal neurologists, neurologists, or pain specialists will be included in the study in the form of available sampling. If they meet the before randomization inclusion criteria we generate random numbers from 1 to 99 using a calculator for each client. If the random number is between 1 and 33, the person will be in the tDCS group, if the random number is between 34 and 66, the person will be in the tACS group, and if the random number is between 67 and 99, the person will be in the control group. If each group is completed, the range of numbers will be reduced by one-third (i.e. 1 to 66) and randomization will be done between the remaining two groups, Blinding description: Participants in two intervention groups and one control group are not aware of which group they are in. The participants of the control group are asked to complete the questionnaires and wait for one month to participate in the research, and during this time they must comply with the condition of not changing the medication prescription. Once at the beginning and once at the end of the period, the questionnaires would get completed by them and after that, if they wish to continue participating in the research, the treatment will also apply for them. N/A Migraine. Intervention 1: Intervention group No.1: A Group that receives the tDCS protocol and comprises 15 people identified by A code. Anodal tDCS will be applied on their left lobe primary motor cortex (M1) with 2mA intensity for 12 consecutive sessions (three days per week), 20 minutes for each session. Intervention 2: Intervention group No.2: A group that receives the tACS protocol and comprises 15 people identified with B code. Alternative stimulation will be applied on their left lobe primary motor cortex (M1) with 2mA intensity and 10Hz frequency for 12 sessions (three sessions per week), 20 minutes for each session. Intervention 3: Control group: A group that comprises 15 people who don't receive any electrical stimulation. They will be told that they're on the waiting list for treatment. They would be asked to complete the questionnaires at the beginning and the end of a month and not to change their pharmaceutic prescription during this period. After the end of the waiting period, if they would like to continue the remedy process, they will receive the tDCS treatment protocol (because of its frequency in research). 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 Data
public Behzad Rigi Kote
Baharan Psychiatric Hospital, above of 54th alley, west Imam Khomeini Blvd., 15 Khordad sq.
Zahedan Iran (Islamic Republic of) 9819713955 +98 54 3351 3778 brkpsycho1988@gmail.com Zahedan University of Medical Sciences scientific Zabihollah Hashemzehi Gonaki
Khatam ol Anbia hospital, Jame Jam blvd.
Zahedan Iran (Islamic Republic of) 9815733345 +98 54 3322 0501 Zabih1966@yahoo.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Suffering from migraine based on the diagnosis of one of internal neurologists, neurologists and pain specialists 18 years 70 years Both Having a history of hospitalization in a psychiatric hospital Suffering from severe depression or anxiety Having a history of cardiovascular diseases (such as high blood pressure) Addiction to alcohol or other substances Suffering from other forms of headache, including tension headaches, sinusitis, and headaches caused by drug abuse Suffering from neurological disorders such as epilepsy, stroke, head and neck trauma, and cerebrovascular diseases Starting the use of medication (in case of first visit) or changing the prescribed medication, from two weeks before the intervention to two weeks after the end of the intervention. Previous history of receiving any other brain stimulation Not having at least primary education G43 Migraine Treatment - Devices Treatment - Devices N/A Intervention group No.1: A Group that receives the tDCS protocol and comprises 15 people identified by A code. Anodal tDCS will be applied on their left lobe primary motor cortex (M1) with 2mA intensity for 12 consecutive sessions (three days per week), 20 minutes for each session. Intervention group No.2: A group that receives the tACS protocol and comprises 15 people identified with B code. Alternative stimulation will be applied on their left lobe primary motor cortex (M1) with 2mA intensity and 10Hz frequency for 12 sessions (three sessions per week), 20 minutes for each session. Control group: A group that comprises 15 people who don't receive any electrical stimulation. They will be told that they're on the waiting list for treatment. They would be asked to complete the questionnaires at the beginning and the end of a month and not to change their pharmaceutic prescription during this period. After the end of the waiting period, if they would like to continue the remedy process, they will receive the tDCS treatment protocol (because of its frequency in research). Pain Perception Score. Timepoint: Before starting and after the ending of intervention. Method of measurement: McGill Pain Perception Questionnaire (MPQ). Severity of migraine symptoms. Timepoint: Before starting and after the ending of intervention. Method of measurement: Ahvaz Migraine Questionnaire (AMQ). Migraine duration. Timepoint: Before starting and after the ending of intervention. Method of measurement: MIDAS Questionnaire. Severity of migraine attack. Timepoint: Before starting and after the ending of intervention. Method of measurement: MIDAS Questionnaire. Number of migraine attacks. Timepoint: Before starting and after the ending of intervention. Method of measurement: MIDAS Questionnaire. Zahedan University of Medical Sciences Approved 2023-04-30 Ethics committee of Zahedan University of Medical Sciences Dr. Hesabi Square, Zahedan University of Medical Sciences compound, Administration building Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)