Objectives: To assess the effect of repetitive trans-cranial magnetic stimulations on tinnitus.
Design: A before after clinical trial.
Setting and conduct: All eligible patients with tinnitus who will refer to the Beasat Hospital during the study period will be enrolled in to the trial.
Inclusion criteria: (a) having tinnitus; (b) age of 18 to 60 years.
Exclusion criteria: (a) history of severe neurological disorders or epilepsy; (b) using pacemaker; (c) using any kind of intracranial devices; (d) being pregnant.
Intervention: Stimulation of the left side of the cortex with rTMS with frequency of 1 Hz and severity of 110% of the threshold for stationary engine and 1200 stimulations for 20 min once a day for three consecutive days.
Control: In comparison with before treatment.
Primary outcome: Assessing the status of tinnitus immediately, one week, and one month after treatment using THI questionnaire.
Secondary outcome: headache immediately, one week, and one month after treatment by question.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403189014N32
Registration date:2014-05-26, 1393/03/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-26, 1393/03/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of repetitive trans-cranial magnetic stimulations on tinnitus in patients with tinnitus: a before after clinical trial
Public title
Effect of repetitive trans-cranial magnetic stimulations on tinnitus in patients with tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) having tinnitus; (b) age of 18 to 60 years.
Exclusion criteria: (a) history of severe neurological disorders or epilepsy; (b) using pacemaker; (c) using any kind of intracranial devices; (d) being pregnant.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomization: Non-randomized.
Blinding: Open label.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2013-05-17, 1392/02/27
Ethics committee reference number
P/16/35/9/714
Health conditions studied
1
Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
Assessing the status of tinnitus
Timepoint
immediately, one week, and one month after treatment
Method of measurement
using THI questionnaire
Secondary outcomes
1
Description
Headache
Timepoint
immediately, one week, and one month after treatment
Method of measurement
by question
Intervention groups
1
Description
Stimulation of the left side of the cortex with rTMS with frequency of 1 Hz and severity of 110% of the threshold for stationary engine and 1200 stimulations for 20 min once a day for three consecutive days.
Category
Treatment - Other
2
Description
In comparison with before treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat Hospital
Full name of responsible person
Maryam Emadi
Street address
Beasat Hospital, Shahed Square, Behesh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences
Full name of responsible person
Maryam Emadi
Position
Master of audiometry
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 1838 0572
Fax
Email
m.emadi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences
Full name of responsible person
Maryam Emadi
Position
Master of audiometry
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 1838 0572
Fax
Email
m.emadi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)