tinnitus. Tinnitus
Conditions
Interventions
Intervention 1: Control group: in this group the intervention is low frequency-tRNS with the same parameters used in the intervention group with one difference concerning the electrode array. In this
Medinateb, Iran) through conductive rubber electrodes, placed in two saline-soaked sponges. In the stimulation mode “noise” there is a random level of current generated for every sample (sampling rate
the probability density function follows a bell-shaped curve. In the frequency spectrum all coefficients have a similar size (“white noise”). The noise signal contains all frequencies up to half of th
Treatment - Devices
Control group: in this group the intervention is low frequency-tRNS with the same parameters used in the intervention group with one difference concerning the electrode array. In this concern the whol
Intervention group: Stimulation is delivered by a battery-driven electrical stimulator (NeuroStim2
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: Right-handedness Chronic nonpulsatile tinnitus (>6 months) Age between 20 and 50 years Normal external and middle ear function and appearance using otoscopy and tympanometry Behavioral pure-tone audiometry threshold levels of =20 dBHL in octave frequencies of 250–2000 Hz and not more than 40 dBHL in frequencies of 4000 -8000 Hz Moderate to severe tinnitus intensity (THI score over 38-76)
Exclusion criteria
Exclusion criteria: Remarkable cognitive problems (MMSE over 20); Previous formal musical training Depression and anxiety (HADS scores less than 11 from 21 for either depression and anxiety) A history of otological, neurological, mental diseases, head trauma, pregnancy, psychiatric disorders, dementia, seizure or any organic diseases that cause tinnitus; Having a pacemaker or defibrillator Taking specific medication that could modify the stimulation effect: (i.e., amine metabolism drugs: citalopram, sulpiride, and pergolide; amino acid metabolism drugs: lorazepam, rivastigmine. Moreover, voltage-sensitive channel blockers: carbamazepine and flunarizine).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tinnitus related loudness. Timepoint: Immediately after the treatment session. Method of measurement: Visual Analogue Scale (VAS-L).;Tinnitus related annoyance(distress). Timepoint: Immediately after the treatment session. Method of measurement: Visual Analogue Scale (VAS-A).;MMN amplitude. Timepoint: Immediately after the treatment session. Method of measurement: MMN software.;MMN area under curve. Timepoint: Immediately after the treatment session. Method of measurement: MMN software.;Mean frequency of EEG waves. Timepoint: Immediately after the treatment session. Method of measurement: Mean frequency of EEG waves.;EEG absolute powers. Timepoint: Immediately after the treatment session. Method of measurement: EEG software.;EEG relative powers. Timepoint: Immediately after the treatment session. Method of measurement: EEG software.;EEG activity in ROIs (region of interest). Timepoint: Immediately after the treatment session. Method of measurement: EEG software (sLORETA). | — |
Secondary
| Measure | Time frame |
|---|---|
| Tinnitus pitch. Timepoint: Before treatment. Method of measurement: Pitch matching. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeid Mahmoudian
Iran University of Medical Sciences
Outcome results
None listed