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Therapeutic effects of transcranial direct current stimulation in chronic tinnitus: Evaluating long term anodal exposure to left auditory cortex

Protocol summary

Summary
This double blinded clinical trial aims to investigate the therapeutic effects of auditory cortex anodal, cathodal, and sham transcranial direct current stimulation (tDCS) on chronic idiopathic tinnitus resistant to medications. Ninety patients, male and female (18 to 70 years old) with chronic drug resistant idiopathic tinnitus are randomly divided into three groups of anodal, cathodal, and sham treatments (n=30). Inclusion criteria are chronic idiopathic tinnitus for more than 6 months, resistance to medications. Exclusion criteria are history of seizure attacks, high blood pressure, pace maker, brain trauma, and severe psychiatric disorders. Anodal stimulation consists of daily one session (2 mA for 20 min with 35 cm2 electrode), 5 consecutive sessions per week for two consecutive weeks (10 sessions) where anode is placed at left auditory cortex and cathode at right auditory cortex. The cathodal stimulation consists of the same protocol while anode at right auditory cortex and cathode at left auditory cortex. In the sham treatment, electrode montage is the same with anodal group, but after 40-50 sec the device will be turned OFF without informing the patients. The primary outcome is score of tinnitus handicap inventory (THI), assessed prior and post interventions (one hour after last session). The secondary outcome is tinnitus loudness and distress which are assessed using a 0 to 10 numerical rating scale prior and post each tDCS session (5 min after end of session), one week, and one month after last tDCS session. Therapeutic effects are compared inter- and intra-group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016110124635N6
Registration date: 2017-06-01, 1396/03/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-01, 1396/03/11
Registrant information
Name
Ali Yadollahpour
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3321 1208
Email address
yadollahpour-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences (U-94187)
Expected recruitment start date
2016-04-29, 1395/02/10
Expected recruitment end date
2016-10-31, 1395/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of transcranial direct current stimulation in chronic tinnitus: Evaluating long term anodal exposure to left auditory cortex
Public title
Transcranial direct current stimulation for chronic tinnitus treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: chronic tinnitus for more than 6 months; resistance to medications; idiopathic tinnitus. Exclusion criteria: history of seizure attacks; high blood pressure; pace maker; brain trauma; severe psychiatric
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Research Committee, Ahvaz Jundishapur University of Medical Sciences
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blv.
City
Ahvaz
Postal code
6135715794
Approval date
2016-02-10, 1394/11/21
Ethics committee reference number
IR.AJUMS.REC.1394.639

Health conditions studied

1

Description of health condition studied
chronic tinnitus
ICD-10 code
H93.1
ICD-10 code description
chronic tinnitus

Primary outcomes

1

Description
Tinnitus Handicap Inventory (THI) Score
Timepoint
Pre intervention, Post intervention at one hour after last transcranial direct current stimulation (tDCS) session and at one month after last tDCS session.
Method of measurement
THI questionnaire

Secondary outcomes

1

Description
tinnitus intensity
Timepoint
Prior and post each transcranial direct current stimulation (tDCS) session (5 min after end of session), one week, and one month after last tDCS session
Method of measurement
Numerical rating scale (0 to 10)

2

Description
Tinnitus distress
Timepoint
Prior and post each transcranial direct current stimulation (tDCS) session (5 min after end of session), one week, and one month after last tDCS session
Method of measurement
Numerical rating scale (0 to 10)

Intervention groups

1

Description
Anodal intervention group (n=30): Treatment protocol consists of daily one session (2 mA for 20 min with 35 cm2 electrode), 5 consecutive sessions per week for two consecutive weeks (10 sessions) where anode is placed at left auditory cortex and cathode at right auditory cortex.
Category
Treatment - Devices

2

Description
Cathodal intervention group (n=30): Treatment protocol consists of daily one session (2 mA for 20 min with 35 cm2 electrode), 5 consecutive sessions per week for two consecutive weeks (10 sessions) where anode is placed at auditory cortex and cathode at left auditory cortex.
Category
Treatment - Devices

3

Description
Sham treatment (n=30): Treatment protocol is the same as anodal treatment, but after 40-50 sec the device will be turned OFF without informing the patients.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Bioelectromagnetic Clinic, Ahvaz Imam Khomeini Hospital
Full name of responsible person
Dr Ali Yadollahpour
Street address
Bioelectromagnetic Clinic, Ahvaz Imam Khomeini Hospital, Azadegan St.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical ُsciences
Full name of responsible person
Behzad Sharif Makhmalzadeh, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blv.
City
Ahvaz
Grant name
Grant code / Reference number
u-94187
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Bioelectromagnetic Clinic, Ahvaz Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sci
Full name of responsible person
Ali Yadollahpour
Position
Head of Clinic/ PhD
Other areas of specialty/work
Street address
Bioelectromagnetic Clinic, Ahvaz Imam Khomeini Hospital, Azadegan St.
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3222 2925
Fax
Email
yadollahpour.a@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Position
ENT
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blv.
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3373 8383
Fax
Email
ahvaz.ent@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bioelectromagnetic Clinic, Ahvaz Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sci
Full name of responsible person
Ali Yadollahpour
Position
Head of Clinic/ PhD
Other areas of specialty/work
Street address
Bioelectromagnetic Clinic, Ahvaz Imam Khomeini Hospital, Azadegan St.
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3222 2925
Fax
Email
yadollahpour.a@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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