Comparison two therapeutic methods (burst repetitive transcranial magnetic stimulation with high frequency repetitive transcranial magnetic stimulation) on compliants of patient with chronic tinnitus.
In this study we use repetitive transcranial magnetic stimulation for suppression of tinnitus in patients with chronic tinnitus. None of the patients have any contraindication for using of magnetic stimulation. Sample size is 80 patients which are devided into two groups. In one group the cases will be undergone burst stimulation with the duration of 40 seconds and frequency is 50hz .the coil must be placed on both side of auditory cortex ,after 15 minute this stage will be repeated. In high frequency group the cases will be undergone 10hz frequency with 25 seconds rest time and 1000 pulse, the coil will be placed only on left auditory cortex and the stimulation will be done weekly for four weeks. Finally ,two groups will be compared using visual analog scale and tinnitus questionnaire at baseline and end of study as well as one month later
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112218438N1
Registration date:2012-01-17, 1390/10/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-17, 1390/10/27
Registrant information
Name
Seyyedeh- Maryam Yazdi- Bahri
Name of organization / entity
Tehran University of Medical Sciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 21 7762 9780
Email address
m-yazdi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rsearch deputy of Tehran University of Medical Sciences
Expected recruitment start date
2011-12-01, 1390/09/10
Expected recruitment end date
2012-03-03, 1390/12/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison two therapeutic methods (burst repetitive transcranial magnetic stimulation with high frequency repetitive transcranial magnetic stimulation) on compliants of patient with chronic tinnitus.
Public title
comparison of therapeutic methods of tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:18-75 age؛ innitus for six month.
Exclusion criteria :menier؛ flacuating hearing loss؛ history of epilepcy ؛ head truma ؛ brain surgery ؛ pace maker؛ using of anticonvulsant or anti psychotic؛ regular using of banzodiazepine ؛pregnant women ؛ history of suicide؛ disease that has interaction with tratment .
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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 Tehran University of Medical Sciences
Street address
6 floor, Central Organization of University, Qods St, Keshavars Avenue
City
Tehran
Postal code
Approval date
2011-11-21, 1390/08/30
Ethics committee reference number
1518/130/د/90
Health conditions studied
1
Description of health condition studied
tinnitus
ICD-10 code
H93.1
ICD-10 code description
tinnitus
Primary outcomes
1
Description
Severity of tinnitus
Timepoint
before treatment, after treatment ,4week after treatment
Method of measurement
Visual analog scale, tinnitus questionnaire
Secondary outcomes
1
Description
complication including headache
Timepoint
after treatment
Method of measurement
check list
2
Description
complication including vertigo
Timepoint
after treatment
Method of measurement
check list
Intervention groups
1
Description
intervention group: burst repetitive transcranial magnetic stimulation with50 hz frequency and for 40 second on each auditory cortex that after 15 minute it will be repeated . it will be done weekly for four weeks
Category
Treatment - Devices
2
Description
control group : tonic repetitive transcranial magnetic stimulation with 10hz frequency ,1000 pulse and 25 seconds rest time only on left auditory cortex.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitation Clinic of Firoozgar hospital
Full name of responsible person
Bijan Forough
Street address
Physical medicine and Rehabilitation clinic, Firoozgar hospital, Behafarin St.Valiasr Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tehran University of Medical Sciences
Full name of responsible person
Ali Akbar Fotohi
Street address
Research deputy, Central building of Tehran University of Medical Sciences, Qods St, Keshavarz Avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tehran 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
Tehran university of Medical Sciences and Health Services
Full name of responsible person
Seyyedeh- Maryam Yazdi -Bahri
Position
Physical Medicine and Rehabilitation assistant
Other areas of specialty/work
Street address
No.6, Ahmadi Alley, Khaje nasir St
City
Tehran
Postal code
Phone
+98 21 7762 9780
Fax
Email
m-yazdi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of Medical Sciences and Health Services
Full name of responsible person
Tannaz Ahadi
Position
Physiatrist
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation clinic, Firoozgar hospital, Behafarin St, Valiasr Square
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
+98 21 8894 2970
Email
t-ahadi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences and health Services