Investigating the effect of treatment with Cerebrum electrical stimulation on tinnitus patients with normal hearing sensitivity: A Randomized Clinical trial study
Assessing the Effect of Electrical Stimulation in Patients with Chronic Tinnitus and Normal Hearing Sensitivity
Design
patients are randomly divided into two treatment groups and a placebo group (sham control). Each group will have 20 patients. The clinical trial has a control group, with parallel groups, randomized, on 40 patients.
Settings and conduct
Patients with tinnitus disease and with normal hearing sensitivity are selected for this study after hearing evaluations by audiometric specialists referring to Imam Khomeini Hospital
Participants/Inclusion and exclusion criteria
Tinnitus patients with normal hearing sensitivity are selected for this study after hearing diagnosis of chronic tinnitus problem. People who have contraindications for tDCS are: cardiovascular patients, pregnant women, brain patients, people with a history of brain surgery, people with metal or electronic implants, and people with a history of mental and psychological diseases.
Intervention groups
بیماران گروه درمانی پروتکل تابش جریان مستقیم فراقشری (tDCS) را به صورت جریان 2 میلی آمپر، مدت زمان 20 دقیقه، الکترود آند بر روی قشرشنوایی نیمکره چپ (T3) و الکترود کاتد بر روی قشر شنوایی نیمکره راست (T4) کار گذاشته می‌شود. مکان جایگذاری الکترود جریان با استفاده از استاندارد الکترودگذاری 10-20 نوار مغزی انجام می‌شود. از الکترودهای مربعی 35 سانتی متر مربع کربنی که با محلول سالین 0.9 درصد مرطوب شده تا رسانایی مطلوب برای ایجاد جریان را ایجاد کند. تابش روزانه یک بار و به مدت 10 روز انجام می‌شود (دستگاه Oasis Pro). شاخص درمانی اولیه میزان بلندی صدای وزوز و میزان آزردگی بیمار ناشی از وزوز می‌باشد. میزان بلندی صدا بوسیله ی پرسشنامه VAS ارزیابی می شود که با استفاده از مقیاس عددی رتبه‌ای 0 تا 10 تعیین می‌شود و مقادیر بزرگتر نشان دهنده ی شدت بیشتر بلندی صدای وزوز می باشد. میزان آزردگی بیمار ناشی از وزوز بوسیله ی پرسشنامه ی THI ارزیابی می شود
Main outcome variables
loudness and annoyance before and after treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240503061635N1
Registration date:2024-07-14, 1403/04/24
Registration timing:prospective
Last update:2024-07-14, 1403/04/24
Update count:0
Registration date
2024-07-14, 1403/04/24
Registrant information
Name
Mehdi Karimipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 0074
Email address
karimipour.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of treatment with Cerebrum electrical stimulation on tinnitus patients with normal hearing sensitivity: A Randomized Clinical trial study
Public title
Investigating the effect of treatment with Cerebrum electrical stimulation on tinnitus patients with normal hearing sensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundishapur University of Medical Sciences
Street address
Iran - Ahvaz - Golestan Boulevard - Jundishapur University
City
Ahwaz
Province
Khouzestan
Postal code
1579461357
Approval date
2024-07-02, 1403/04/12
Ethics committee reference number
IR.AJUMS.REC.1403.148
Health conditions studied
1
Description of health condition studied
Tinnitus - the beauty of hearing
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
loudness level of tinnitus
Timepoint
10 DAYS
Method of measurement
Transcortical direct current (tDCS) irradiation at a current of 2 mA
Secondary outcomes
1
Description
The degree of patient annoyance caused by tinnitus by THI questionnaire
Timepoint
10 DAYS
Method of measurement
THI questionnaire
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized Clinic of Imam Khomeini Hospital
Full name of responsible person
Nader Saki
Street address
Azadegan Street, Ahvaz, Khuzestan Province
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۹۳۶۷۳۱۶۶
Phone
+98 61 3222 2922
Email
Mehdi.karimipour88@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nader saki
Street address
Khuzestan Province, Ahvaz, Boulevard of Medical Sciences, 7MW2+W4Q
City
Ahvaz
Province
Khouzestan
Postal code
6135733111
Phone
+98 61 3333 0020
Email
info@ajums.ac.ir
Grant name
Jundishapur University Research Assistant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Jundishapur University of Ahvaz
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
Ahvaz University of Medical Sciences
Full name of responsible person
Nader saki
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
The Jundishapur University of Medical Sciences is located in the cJundishapur University of Medical Sciences Golestan Boulevard, University City Ahvaz, Khuzestan Province Iran
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357a
Phone
+98 61 3314 0000
Email
saki-n@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nader saki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
اهواز ، بلوار علوم پزشکی ، علوم پزشکی جندی شاپور
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3314 0000
Email
saki-n@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nader Saki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Ahvaz - Boulevard of Medical Sciences - Jundishapur Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61365715794
Phone
+98 61 3314 0000
Email
saki-n@ajums.ac.ir
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
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available