The effect of electrical stimulation on treatment of chronic tinnitus

Phase 1

Conditions: tinnitus.
Tinnitus

Registration Number: IRCT2017050724360N2

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 32

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

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).

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures