Determining the efficacy of Repetitive Magnetic Brain Stimulation (RTMS) in tinnitus disorder
Design
The design of this research is a semi-experimental type of pre-test-post-test. Using the Tinnitus Questionnaire (THI), 30 patients were selected as the sample size using available sampling method using Cochran's formula.
Settings and conduct
It includes all people (both men and women) who came to Al-Zahra Hospital and Ayatollah Kashani Hospital (Isfahan) in 1402 with complaints of tinnitus. People are compared in the beginning and before the rtms method (pre-test) and then after the implementation of the RTMS method again and as a post-test, and the post-test will be performed for them. The instrument used is the tinnitus questionnaire (THI), which is implemented as a post-test and a pre-test. The method of semi-experimental work is of pre-test-post-test type. And the patients are in the process of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) A woman or man with tinnitus with an average age of 30 to 65 years
2) No simultaneous use of drug treatments
3) Not using other treatment methods, including surgery and medicine, in the last 6 months
4) Sound perception without any external physical stimulus
Exclusion criteria
1) Having a middle ear infection
2) Tooth and sinus infection
3) Having a job and activity with noise pollution
Intervention groups
Patients treated with 10 sessions of RTMS (Repetitive Transcranial Magnetic Stimulation) with an English Magstim device with plating site in cases of bilateral tinnitus in the left temporal lobe and in cases of unilateral tinnitus in the opposite temporal lobe
Main outcome variables
tinnitus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240319061335N1
Registration date:2024-04-15, 1403/01/27
Registration timing:registered_while_recruiting
Last update:2024-04-15, 1403/01/27
Update count:0
Registration date
2024-04-15, 1403/01/27
Registrant information
Name
Toraj Khaledian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3522 8310
Email address
khaledian12@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-24, 1403/01/05
Expected recruitment end date
2024-05-25, 1403/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of RTMS on tinnitus patients
Public title
Investigating the effect of RTMS on tinnitus patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A woman or man with tinnitus with an average age of 30 to 65 years2) ) No simultaneous use of drug treatments3) 4) 5)
Using the Tinnitus Handicap Inventory questionnaire2
Not using other treatment methods, including surgery and medicine, in the last 6 months
Absence of other effective diseases
Sound perception without any external physical stimulus
Exclusion criteria:
Having a middle ear infection
Having a job and activity with noise pollution
Tooth and sinus infection
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
Hezargarib, University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-02-13, 1402/11/24
Ethics committee reference number
IR.MUI.MED.REC.1402.431
Health conditions studied
1
Description of health condition studied
tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
tinnitus
Timepoint
tinnitus before the start of the intervention (first day); It is measured 20 days after the start of treatment and 50 days after the start of treatment in the follow-up phase.
Method of measurement
Tinnitus Handicap Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: RTMS (Repetitive Transcranial Magnetic Stimulation) is a non-invasive method in the treatment of tinnitus in such a way that by providing electromagnetic pulses through electrodes placed on the head, it can reduce the excitability of neurons and neurotransmitters related to tinnitus and as a result of reducing the intensity of tinnitus. This study has an experimental group and it is evaluated in the form of pre-test-post-test and does not have a control group. Intervention group: the sample size of 30 people is selected using the available sampling method. People are compared in the beginning and before the rtms method (pre-test) and then after the implementation of the RTMS method again and as a post-test, and the post-test will be performed for them. The instrument used is the Tinnitus Handicap Inventory (THI), which is administered as a post-test and a pre-test.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital - Isfahan University of Medical Sciences- Alzahra hospital - Isfahan University of
Full name of responsible person
Mehrdad Rogha
Street address
Hezar jarib, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 918 781 0408
Email
rogha@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
By the patient and resident (There is no cost at all)
Full name of responsible person
Mehrdad Rogha
Street address
Hezar garib, isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 918 781 0408
Email
rogha@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
By the patient and resident (There is no cost at all)
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Rogha
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar jarib, Isfahan University of MedicalSciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 111 4856
Email
rogha@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Rogha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezarjarib, Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
rogha@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Rogha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezargarib, Isfahan University of MedicalSciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
rogha@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It is confidential and is possible only with the consent of the patient