Evaluating the effectiveness of repeated sessions of transcranial direct current stimulation for the treatment of subjective tinnitus, a double blind randomized controlled trial. subjects: Patients over 18 years of age; with chronic subjective tinnitus; lasting more than 6 month; without history of traumatic brain injury; intake of antipsychotic, antiepileptic, benzodiazepines stopped less than 1 month ago; cognition impairment; psychiatric disorder; pregnancy; previous experience of receiving tDCS. Sample size: 20 Intervention: transcranial direct current stimulation versus sham stimulation. Patients receive 5 sessions of real or sham stimulation. Outcome: change in tinnitus loudness or distress assessed with visual analog scale and Tinnitus Handicap Inventory (THI(
General information
Acronym
"transcranial Direct Current Stimulation, tDCS"
IRCT registration information
IRCT registration number:IRCT2014082018871N1
Registration date:2014-08-26, 1393/06/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-26, 1393/06/04
Registrant information
Name
Zohreh Sadat Mirshaki
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1679
Email address
zohrehmirshaki@yahoo.com
Recruitment status
Recruitment complete
Funding source
Iran Uiversity of Medical Science
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Repeated sessions of transcranial direct current stimulation for the treatment of chronic subjective tinnitus
Public title
Evaluating effectiveness of transcranial direct current stimulation for treatment of tinnitus.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients over 18 years of age; with chronic subjective tinnitus; lasting more than 6 month
Exclusion criteria: Fluctuating audition; epilepsy; history of traumatic brain injury; intake of antipsychotic, antiepileptic, benzodiazepines stopped less than 1 month ago; intake of ototoxic medications; cognition impairment; psychiatric disorder including suicide attempt; cochlear implant; cardiac pacemakers; pregnancy; comorbidities interfering with intervention; previous experience of receiving tDCS
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Iran Uiversity of Medical Science
Street address
Hemmat highway, between Sheykhfazlollah and Chamran h
City
tehran
Postal code
Approval date
2014-04-26, 1393/02/06
Ethics committee reference number
١٠٥/٣٦٥/د/٩٣
Health conditions studied
1
Description of health condition studied
tinnitus
ICD-10 code
H93.1
ICD-10 code description
tinnitus
Primary outcomes
1
Description
loudness of tinnitus
Timepoint
before and after each session, 2 weeks after last session
Method of measurement
visual analog scale
2
Description
distress resultinf from tinnitus
Timepoint
before and after evry session,2 weeks after last session
Method of measurement
visual analog scale
3
Description
disability resulting from tinnitus
Timepoint
before first session, immediately after last session, 2 weeks after last session
Method of measurement
Persian language version of the "Tinnitus Handicap Inventory"
Secondary outcomes
1
Description
any side effect
Timepoint
during, immediatelya after each session,2 weeks after last session.
Method of measurement
reported by patient
Intervention groups
1
Description
Intervention :
for all patients the anode electrode is placed over the left temporoparietal area and the cathode electrode over right supraorbital area. during real stimulation 20 minutes of DC stimulation at 2 mA is delivered.
Category
Treatment - Devices
2
Description
for patients in control group, after placement of electrode the DC stimulator is turned on. after initial ramp up the device is turned off and the patient receive no more stimulation for the rest of the time. for all patients the device in placed out of sight, behind the subject