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IRCT20240503061635N1 IRCT 2024-07-14 Ahvaz University of Medical Sciences Investigating the effect of treatment with Cerebrum electrical stimulation on tinnitus patients with normal hearing sensitivity Investigating the effect of treatment with Cerebrum electrical stimulation on tinnitus patients with normal hearing sensitivity: A Randomized Clinical trial study 2024-07-22 anticipated 80 Complete https://irct.ir/trial/76655 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with qualified criteria will be divided into two groups using random block design. Online website (https://www.seaaledenvelope.com) is used to generate a random list based on the desired sample size and block size 4. After creating a list, each patient will be identified with a unique code during the study. 20 people are selected for the intervention group and 20 are selected for the Sham Group. N/A Tinnitus - the beauty of hearing. Intervention 1: Each group will have 20 patients. The patients of the treatment group received transcortical direct current radiation protocol (tDCS) in the form of a current of 2 mA, a duration of 20 minutes, the anode electrode was placed on the auditory cortex of the left hemisphere (T3) and the cathode electrode was applied on the auditory cortex of the right hemisphere (T4). Placement of the current electrode is performed using the standard electrode placement of 10-20 EEG. of 35 cm2 square carbon electrodes moistened with 0.9% saline solution to create the desired conductivity for generating current. Irradiation is done once a day for 10 days (Oasis Pro device). The primary therapeutic index is the loudness of the tinnitus and the patient's annoyance caused by the tinnitus. The loudness of the voice is evaluated by the VAS questionnaire, which is determined using a numerical scale of 0 to 10, and the larger values ​​indicate the greater intensity of the loudness of the buzzing sound. The degree of annoyance of the patient caused by tinnitus is evaluated by the THI questionnaire, which consists of 25 questions and each question is answered as yes/no and sometimes, and scores of 4, 0, and 2 are given to each answer, respectively. Scores between 0-100 are obtained and higher values ​​indicate higher intensity of irritation caused by tinnitus. The loudness of tinnitus and its annoyance are measured before the beginning of the treatment sessions and one week and two weeks after the end of the treatment sessions and are compared for each patient. Also, the difference between these values ​​between the active treatment group and the placebo group (sham control) is also compared. Intervention 2: Control group: Control group: In the patients of the control group, the electrode is connected, but no electrical stimulation is applied and it only has a psychological aspect. 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 Nader saki
The Jundishapur University of Medical Sciences is located in the cJundishapur University of Medical Sciences Golestan Boulevard, University City Ahvaz, Khuzestan Province Iran
Ahvaz Iran (Islamic Republic of) 15794- 61357a +98 61 3314 0000 saki-n@ajums.ac.ir Ahvaz University of Medical Sciences scientific Nader saki
اهواز ، بلوار علوم پزشکی ، علوم پزشکی جندی شاپور
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3314 0000 saki-n@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients with tinnitus and natural hearing sensitivity are selected by ENT specialists and authentic evaluations by ENT specialists and diagnosed chronic tinnitus problems for this study. Patients with idiopathic tinnitus who have not responded to drug treatments are selected for this program. The age range is from 20 to 70 years. 20 years 70 years Both Cardiovascular patients pregnant women Brain patients History of brain surgery People with metal or electronic implants People with a history of mental illness psychological People with a history of alcohol and drug abuse H93.1 Tinnitus Treatment - Devices Placebo Each group will have 20 patients. The patients of the treatment group received transcortical direct current radiation protocol (tDCS) in the form of a current of 2 mA, a duration of 20 minutes, the anode electrode was placed on the auditory cortex of the left hemisphere (T3) and the cathode electrode was applied on the auditory cortex of the right hemisphere (T4). Placement of the current electrode is performed using the standard electrode placement of 10-20 EEG. of 35 cm2 square carbon electrodes moistened with 0.9% saline solution to create the desired conductivity for generating current. Irradiation is done once a day for 10 days (Oasis Pro device). The primary therapeutic index is the loudness of the tinnitus and the patient's annoyance caused by the tinnitus. The loudness of the voice is evaluated by the VAS questionnaire, which is determined using a numerical scale of 0 to 10, and the larger values ​​indicate the greater intensity of the loudness of the buzzing sound. The degree of annoyance of the patient caused by tinnitus is evaluated by the THI questionnaire, which consists of 25 questions and each question is answered as yes/no and sometimes, and scores of 4, 0, and 2 are given to each answer, respectively. Scores between 0-100 are obtained and higher values ​​indicate higher intensity of irritation caused by tinnitus. The loudness of tinnitus and its annoyance are measured before the beginning of the treatment sessions and one week and two weeks after the end of the treatment sessions and are compared for each patient. Also, the difference between these values ​​between the active treatment group and the placebo group (sham control) is also compared. Control group: Control group: In the patients of the control group, the electrode is connected, but no electrical stimulation is applied and it only has a psychological aspect. Loudness level of tinnitus. Timepoint: 10 DAYS. Method of measurement: Transcortical direct current (tDCS) irradiation at a current of 2 mA. The degree of patient annoyance caused by tinnitus by THI questionnaire. Timepoint: 10 DAYS. Method of measurement: THI questionnaire. Jundishapur University of Ahvaz Approved 2024-07-02 Ethics Committee of Jundishapur University of Medical Sciences Iran - Ahvaz - Golestan Boulevard - Jundishapur University Ahwaz Khouzestan Iran (Islamic Republic of)