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IRCT20220625055275N1 IRCT 2022-09-15 Ardabil University of Medical Sciences The effectiveness of direct current transcranial stimulation (tDCS) on the improvement of the attention network Behavioral and electrophysiological study of the effectiveness of direct current transcranial stimulation (tDCS) on the improvement of the attention network in tinnitus sufferes 2022-06-27 anticipated 30 Complete https://irct.ir/trial/64419 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: To group the subjects, we will do the following steps: Step 1: We set the values of F and M equal to the number of women and men, respectively (F and M will be at least 15). Step 2: We assign numbers 1 to F to each of the female subjects and numbers 1 to M to the male subjects. Step 3: We execute the command sample(1:F,7) in R statistical software. This command will result in 7 people (approximately 50% of the 15 female subjects) being randomly selected. Step 4: We execute the sample(1:M,8) command in R statistical software. This command will result in 8 people (approximately 50% of the 15 male subjects) being randomly selected. Step 5: Men and women whose numbers are extracted in step 3 and step 4 will be included in the experimental group. Step 6: The remaining 8 women and 7 men will be in the control group. Note: It should be noted that if, after this grouping, the age was heterogeneous between the two experimental and control groups, the age variable can be entered as an co-variate in the MANCOVA model, Blinding description: In each clinical trial design, three groups can influence the results of the study. Experiments, researcher, evaluator or analyst. In this study, by randomly selecting participants in two experimental and control groups and applying independent variables to both groups, which are in one sham and play the role of placebo. Also, the analyst is not aware of the sham of the intervention in the group and they become practically blind. N/A Attention network. Intervention 1: Intervention group: Transcranial direct current stimulation (tDCS) in this study, this treatment method will be provided during 10 sessions and 3 sessions per week. In each session for 20 minutes, the current intensity of 2 mA will be applied to the participants in the experimental group. Intervention 2: Control group: Control group: transcranial direct current stimulation (tDCS) in this study, this treatment method will be provided during 10 sessions and 3 sessions per week. In each session, for 30 seconds, the current intensity of 2 mA will be applied to the control (sham) group.Control group: transcranial direct current stimulation (tDCS) in this study, this treatment method will be provided during 10 sessions and 3 sessions per week. In each session, for 30 seconds, the current intensity of 2 mA will be applied to the control (sham) group. 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. I will publish it if necessary
public Dr. Mansour Bayrami
Building No. 2, Faculty of Educational Sciences and Psychology,Tabriz University29 Bahman Blvd,Tabriz,
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3339 2116 Dr.bayrami@yahoo.com The University of Tabriz scientific Dr. Masoor Bayrami
Building No. 2, Faculty of Educational Sciences and Psychology,Tabriz University29 Bahman Blvd,Tabriz,Tabriz
Tabriz Iran (Islamic Republic of) 5166616471 +98 41 3339 2133 Dr.bayrami@yahoo.com The University of Tabriz Iran (Islamic Republic of) Being right-handed Being in the age range of 18-55 years Chronic tinnitus for more than six months Achieve a score of more than 58 in the tinnitus disability questionnaire Having normal hearing , Having normal or corrected vision Complete the consent form to participate in the training program Lack of acute psychological problems (based on the individual's own opinion and the researcher's interview) Lack of a history of obvious neurological and cognitive diseases and head trauma 18 years 55 years Both Therapeutic intervention with the help of other methods during the research History of seizures, brain tumors, strokes and bleeding Having substance abuse Left-handedness or absence of a dominant hand Not being in the age range of 18-55 No tinnitus or tinnitus for less than six months Obtaining a score less than 58 in the tinnitus disability questionnaire Having a hearing loss Having an uncorrected vision problem Treatment - Other Treatment - Other Intervention group: Transcranial direct current stimulation (tDCS) in this study, this treatment method will be provided during 10 sessions and 3 sessions per week. In each session for 20 minutes, the current intensity of 2 mA will be applied to the participants in the experimental group. Control group: Control group: transcranial direct current stimulation (tDCS) in this study, this treatment method will be provided during 10 sessions and 3 sessions per week. In each session, for 30 seconds, the current intensity of 2 mA will be applied to the control (sham) group.Control group: transcranial direct current stimulation (tDCS) in this study, this treatment method will be provided during 10 sessions and 3 sessions per week. In each session, for 30 seconds, the current intensity of 2 mA will be applied to the control (sham) group. Attention network alerting component:in the behavioral test, a cross (+) is displayed in the center of the screen, with flankers in the form of congruent (<<<<<) or incongruent (>>>><>>>>) above or below it appear. Participants are required to focus on the cross during the test period and when the flankers appear, with high speed and accuracy in the direction of the central arrow using the mouse (the left mouse key for when the central arrow tip is to the left and the key the right side of the mouse when the tip of the central arrow is to the right). The alert component is obtained from the fraction of the reaction time and the number of errors of the central sign from the alarm without a sign. Timepoint: After randomization into two experimental and control groups, the pre-test is performed, then the intervention is carried out in 10 sessions and transcranial stimulation is applied in 3 sessions every week for 20 beats, then the post-test is performed. Method of measurement: Attention network test, quantitative electroencephalography. Orientation component of the attention network: the orientation component is obtained from the fraction of the reaction time and the number of spatial cue errors from the central cue. Timepoint: After randomization into two experimental and control groups, the pre-test is performed, then the intervention is carried out in 10 sessions and transcranial stimulation is applied in 3 sessions every week for 20 beats, then the post-test is performed. Method of measurement: Attention network test, quantitative electroencephalography. Executive component of attention network:The executive control component is obtained from the fraction of the reaction time and the number of errors of the incongruent arrows from the congruent ones. Timepoint: After randomization into two experimental and control groups, the pre-test is performed, then the intervention is carried out in 10 sessions and transcranial stimulation is applied in 3 sessions every week for 20 beats, then the post-test is performed. Method of measurement: Attention network test, quantitative electroencephalography. The absolute power of the alpha wave in the frontal region. Timepoint: After randomization into two experimental and control groups, the pre-test is performed, then the intervention is carried out in 10 sessions and transcranial stimulation is applied in 3 sessions every week for 20 beats, then the post-test is performed. Method of measurement: Quantitative electroencephalography. Improvement of attention after intervention based on Tinnitus Disability Questionnaire score. Timepoint: Before and after intervention sessions. Method of measurement: 25-question tinnitus disability questionnaire. I have no sponsorship or financial prohibition from an institution or organization Approved 2022-07-31 Research Ethics Committees of university of Tabriz 29 Bahman Boulevard, Tabriz University, Central Library and University Document Center, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)