Determination of the effect of neurofeedback sessions on Tinnitus treatment
Design
Clinical trial is without a control group, without blinding and without randomization.
Settings and conduct
This is a clinical trial study in patients with Tinnitus referred to the ENT clinic of Alzahra and Kashani Hospitals of Isfahan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The patient has a subjective tinnitus;
Age over 18;
Have a natural hearing threshold;
Exclusion criteria:
Not consent to participate in the study at any time of the study
Intervention groups
The intervention group includes patients with drug-resistant tinnitus, who receive the use of Neurofeedback sessions as intervention. Neurofeedback sessions are designed by a psychiatrist and use the Tinnitus Software and Suite Document. This software has open display sessions so the psychiatrist decides when to end the sessions. The software is based on two scripts: the Tinnitus Training Script, based on the Dorhman protocol, and the General Tinnitus Training Script designed by Linda Walker. The first one includes single feedback animation for 30 minutes, and the second one is a three ten-minute tasks with different animation feedbacks. In both ways, there are two minutes post and pre baseline. All scripts focus on parameters that include alpha / delta peak to peak ratio at f3, f4, fc1, fc2, and also in open display sessions associate with EEG assembly, other parameters such as alpha only, delta only, Gama only will be check.
Main outcome variables
The Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale are completed before starting the neurofeedback for all of the patients. After the end of neurofeedback sessions, one month, three months and six months afterwards, the patients again will complete this questionnaire and this scale will be completed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N30
Registration date:2019-05-01, 1398/02/11
Registration timing:registered_while_recruiting
Last update:2019-05-01, 1398/02/11
Update count:0
Registration date
2019-05-01, 1398/02/11
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of neurofeedback sessions on reduction of tinnitus rate in patients with drug resistance Tinnitus
Public title
Evaluation of the therapeutic effect of neurofeedback sessions on tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has subjective Tinnitus
-Age over 18 years
Have normal hearing threshold
No neurological lesions such as epilepsy, Parkinson's and Alzheimer's
Exclusion criteria:
Any patient dissatisfaction to participate in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
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
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical sciences, Hezar Jareeb street,Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2018-12-31, 1397/10/10
Ethics committee reference number
IR.MUI.MED.REC.1397.253
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 Handicap Inventory questionnaire scale
Timepoint
before starting the neurofeedback, After the end of neurofeedback sessions, one month, three months and six months afterwards
Method of measurement
Tinnitus Handicap Inventory questionnaire
2
Description
Visual Analogue Scale for Tinnitus in the ears of patients
Timepoint
before starting the neurofeedback, After the end of neurofeedback sessions, one month, three months and six months afterwards
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Based on inclusion and exclusion criteria, 30 patients with Tinnitus are selected who are resistant to medical treatments. Neurofeedback sessions are designed by a psychiatrist and use the Tinnitus Software and Suite Document.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Seyedeh Mahboube Nazari
Street address
Kashani Hospital, Kashani Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
1435915371
Phone
+98 31 3386 6266
Email
kashani@mui.ac.ir
Web page address
http://kashani.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo Javanmard
Street address
Isfahan University of Medical Sciences, Hezar jareeb street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mojtaba Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Esfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 913 313 9294
Email
manyekdoost@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mojtaba Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Esfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 913 313 9294
Email
manyekdoost@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mojtaba Abtahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Esfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 913 313 9294
Email
manyekdoost@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
Immediately after publishing the study results
To whom data/document is available
For all who need this data
Under which criteria data/document could be used
Use of data is subject to copyright laws.
From where data/document is obtainable
Email the study manager to receive the data
What processes are involved for a request to access data/document