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IRCT2017050724360N2 IRCT 2017-06-30 Iran University of Medical Sciences The effect of electrical stimulation on treatment of chronic tinnitus - The effect of a multisite transcranial random noise stimulation (tRNS) on tinnitus loudness, distress, mismatch negativity response (MMN) and electroencephalography (QEEG) in subjects with chronic tinnitus 2017-06-01 anticipated 32 Complete https://irct.ir/trial/20586 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: Patients will be simply randomized into two groups, but they will take the two treatment stages (placebo & active) without randomization i.e in all cases we will begin with the Sham stimulation. The way of randomization is by drawing a number between 1-32 where numbers from 1 to 16 is referring to the intervention group while numbers from 17 to 32 is referring to the control group. The randomization will be done by computer using Matlab, Blinding description: All participants have no information about kind of their treatment session (placebo or real). They also have no information about in which group they are participating. However, the researcher knows these details and he is the performer of the experiment. 1 tinnitus. 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 concern the whole 20 minutes session will be applied over the auditory cortex (T3, T4). Before the active session the patient will take a sham stimulation session. Intervention 2: Intervention group: Stimulation is delivered by a battery-driven electrical stimulator (NeuroStim2; 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 1280 samples/s). The random numbers are normally distributed; 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 the sampling rate, i.e., a maximum of 640 Hz. In our experiment this frequency spectrum is separated into a low (0.1–100 Hz)-frequency which will be applied over the auditory cortex (AC-tRNS) for 10 minutes followed by the high (101–640 Hz)-frequency spectrum stimulation of the DLPFC (DLPFC-tRNS) for the following 10 minutes to have an active stimulation session of 20 minutes called the multisite one. Because of the statistical characteristics, the signal has no DC offset, provided that the offset is set to zero and the intensity of alternating current is 2.0 mA which, is initially increased in a ramp-like fashion over several seconds (30 s) until reaching 2.0 mA. In the AC-tRNS, the electrodes is placed over the left and right auditory cortices (T3, T4), while in the DLPFC-tRNS they will be placed over the right DLPFC (F4) and the left frontopolar cortex (FP1) as determined by the International 10/20 Electroencephalogram System. In the stimulation mode “sham” the current is switched off automatically after a ramp-in of 30 seconds. Each patient in the group will take a sham stimulation session before taking his/her active intervention without knowing which of them is placebo. The session will be given in the same mentioned protocols in active intervention concerning electrode arrays and the time of the session. Undecided - It is not yet known if there will be a plan to make this available
public Saeid Mahmoudian
Hazrat-e Rasool General Hospital, Niyayesh St., Satarkhan St., Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 2828 mahmoudian.s@iums.ac.ir Iran University of Medical Sciences scientific Akram Pourbakht
Faculty of Rehabilitation, Madadkaran st., Shahnazari st., Madar sq., Mirdamad
Tehran Iran (Islamic Republic of) 13487 - 15459 +98 21 2225 0541 pourbakht.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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) 20 years 60 years Both 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). H93.1 Tinnitus Treatment - Devices 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 whole 20 minutes session will be applied over the auditory cortex (T3, T4). Before the active session the patient will take a sham stimulation session. Intervention group: Stimulation is delivered by a battery-driven electrical stimulator (NeuroStim2; 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 1280 samples/s). The random numbers are normally distributed; 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 the sampling rate, i.e., a maximum of 640 Hz. In our experiment this frequency spectrum is separated into a low (0.1–100 Hz)-frequency which will be applied over the auditory cortex (AC-tRNS) for 10 minutes followed by the high (101–640 Hz)-frequency spectrum stimulation of the DLPFC (DLPFC-tRNS) for the following 10 minutes to have an active stimulation session of 20 minutes called the multisite one. Because of the statistical characteristics, the signal has no DC offset, provided that the offset is set to zero and the intensity of alternating current is 2.0 mA which, is initially increased in a ramp-like fashion over several seconds (30 s) until reaching 2.0 mA. In the AC-tRNS, the electrodes is placed over the left and right auditory cortices (T3, T4), while in the DLPFC-tRNS they will be placed over the right DLPFC (F4) and the left frontopolar cortex (FP1) as determined by the International 10/20 Electroencephalogram System. In the stimulation mode “sham” the current is switched off automatically after a ramp-in of 30 seconds. Each patient in the group will take a sham stimulation session before taking his/her active intervention without knowing which of them is placebo. The session will be given in the same mentioned protocols in active intervention concerning electrode arrays and the time of the session. 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). Tinnitus pitch. Timepoint: Before treatment. Method of measurement: Pitch matching. Iran University of Medical Sciences Approved 2017-04-22 Ethics committee of Iran University of Medical Sciences Milad Tower, Shiekh Fazlollah NouriShahid, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)