The evaluation of effects of electrical stimulation in treatment of patients with chronic tinnitus with normal hearing sensitivity
Design
The clinical trial has an intervention and control group on 40 patients who have been randomized by random allocation method.
Settings and conduct
Patients referred to Tabassom specialized clinic who meet the inclusion criteria will randomly divided into two groups of intervention and control. The intervention group will receive the Transcranial Direct-Current Stimulation radiation (tDCS) protocol in the form of 2 mA current for 20 minutes, while the anode electrode was placed on the left hemisphere cortex (T3) and the cathode electrode was placed on the right hemisphere cortex (T4). The location of the current electrode was determined using the 10-20 electrode electrode standard. 35 cm2 square carbon electrodes moistened with 0.9% saline solution will be used to create the desired conductivity to create current. Irradiation was performed by Oasis pro once a day for 10 days.
Participants/Inclusion and exclusion criteria
People with normal hearing level who suffers from idiopathic tinnitus for at least 3 months and has not responded to medical drugs, will be chosen.
Intervention groups
Patients in the intervention group receive a very weak direct electric current which enters the brain from specific points of the skull and affects the areas involved in tinnitus. The control group will continue the routine medical therapy.
Main outcome variables
Tinnitus loudness according to visual analogue scale rating; Tinnitus handicap scale according to Tinnitus Handicap Inventory Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210429051130N1
Registration date:2021-05-28, 1400/03/07
Registration timing:registered_while_recruiting
Last update:2021-05-28, 1400/03/07
Update count:0
Registration date
2021-05-28, 1400/03/07
Registrant information
Name
Seyyed Mohammad Tabibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 9367 3111
Email address
tabibzadeh.sm@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of effects of electrical stimulation in treatment of patients with chronic tinnitus with normal hearing sensitivity
Public title
The effect of electrical stimulation on tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Tinnitus lasting at least for 3 months.
Idiopathic tinnitus
Normal hearing threshold
Exclusion criteria:
History of neck disorders
Psychological disorders
Brain injury
Epilepsy
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of patients to intervention and control groups by lot. For this purpose, we prepare two sheets and write "Intervention 1" on one and "Intervention 2" on the other. Then, with each patient's visit, one of the sheets is randomly chosen and the patient is assigned to intervention group 1 or intervention 2.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
24 Metri Ave, Imam Khomeini hospital, Ahwaz city
City
Ahwaz
Province
Khouzestan
Postal code
6193673111
Approval date
2021-04-15, 1400/01/26
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.010
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 loudness according to visual analogue scale rating
Timepoint
Before intervention, 7 and 14 days after intervention
Method of measurement
Visual Analogue Scale Questionnaire
2
Description
Tinnitus handicap scale according to Tinnitus Handicap Inventory Questionnaire
Timepoint
Before intervention, 7 and 14 days after intervention
Method of measurement
Tinnitus Handicap Inventory Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the therapy group will apply the Transcranial direct-current stimulation (tDCS) radiation protocol at 2 mA for 20 minutes while the anode electrode will be applied to the left hemisphere cortex (T3) and the cathode electrode will be applied to the right hemisphere cortex (T4). The placement location of the current electrode will be determined using the 10-20 electrode electrode standard. 35 cm2 square carbon electrodes moistened with 0.9% saline solution will be used to create the desired conductivity to create the current. Irradiation will be performed by Oasis pro device once a day for 10 days.
Category
Treatment - Other
2
Description
Control group: In the sham tDCS (control) group, the electrode montage will the same as for the intervention group, but the device will be turned off after 30 seconds without the participant's knowledge.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
ENT Clinic, Imam Khomeini Hospital, Ahvaz, Iran
Full name of responsible person
Soheila Nikakhlagh
Street address
ENT Clinic, Imam Khomeini Hospital, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6193665115
Phone
+98 61 3292 6850
Email
nikakhlagh-s@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Soheila Nikakhlagh
Street address
Golestan Ave, Ahwaz uneversity of medical science
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 4155
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
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
Seyyed Mohammad Tabibzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
24 Metri Ave, Imam Khomeini hospital, ENT department, Ahwaz city