]>
IRCT20140616018118N3 IRCT 2018-06-10 ENT and Head & Neck Research Center The Efficacy of Infra-low-frequency Transcranial Magnetic Stimulation and Evaluation of TMS-evoked Potentials in Subjects with Chronic Tinnitus: A Double-blind, randomized, controlled trial The Efficacy of Infra-low-frequency Transcranial Magnetic Stimulation and Evaluation of TMS-evoked Potentials in Subjects with Chronic Tinnitus: A Double-blind, randomized, controlled trial 2018-06-22 anticipated 40 Complete https://irct.ir/trial/16525 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: controlled randomized trial, Randomization description: Simple-individual-statistical software, Blinding description: participants are not Informed which kind of treatment They Receive. Investigator and data analyzer don't know any information about recorded data. N/A Tinnitus. Intervention 1: Patients group A: in the first and 5th sessions, 5 minutes of Sham Stimulation at a rate of 0.5 Hz, 2 minutes of merely EEG recording ,15 minutes of active TMS with a rate of 0.5 Hz and an intensity of 110% resting motor threshold will be applied respectively. During these two sessions ongoing EEG is being recorded and the coil is placed at Left TemporoParietal (LTP) region. In the second, third and fourth sessions 20 minutes of only active TMS at a rate of 0.5 Hz and an intensity of 110% resting motor threshold will be applied to LTP region. Intervention 2: Patients Group B: for this group the treatment-investigative sessions will be the same as patients group A, with the difference that the stimulations are applied at the Left Dorsolateral Prefrontal Cortex (Left DLPFC). Intervention 3: Normal group C: During one session, 5 minutes of Sham Stimulation at a rate of 0.5 Hz, 2 minutes of merely EEG recording ,15 minutes of active TMS with a rate of 0.5 Hz and an intensity of 110% resting motor threshold will be applied respectively. During the session ongoing EEG is being recorded and the coil is placed at Left TemporoParietal region. Intervention 4: Normal group D: During one session each participant will receive interventions exactly the same as normal Group C with the difference that the stimulations are applied at Left Dorsolateral Prefrontal Cortex (Left DLPFC). Yes - There is a plan to make this available What will be shared: TMS-EEG data in tinnitus and normal subjects When: About January 2020 To whom: Professors and faculty members of universities Conditions: Research Where to obtain: DR. ُSaeid Mahmoodian How to obtain: Contact with DR. Mahmoodian Comments:
public DR. Saeid Mahmoudian
Hazrat Rasoul Akram Hospital-Tehran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6650 4294 mahmoudian.s@iums.ac.ir ENT and Head & Neck Research Center scientific DR. Saeid Mahmoudian
Hazrat Rasoul Akram Hospital-Sattarkhan
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6650 4294 mahmoudian.s@iums.ac.ir ENT and Head & Neck Research Center Iran (Islamic Republic of) Normal hearing Right Handed Bilateral Tinnitus Tinnitus Involvment more than 6 month Informed Consent Tinnitus Loudness more than 6 dB SL THI Score greater than 58 VAS Score greater than 4 of 7 18 years 60 years Both History of seizure, stroke, and severe physical illness Metal implants or cardiac pacemaker Significantly increased intracranial pressure History of craniocerebral surgery Pregnancy Severe alcohol abuse History of emotional disorder before the onset of illness Participation in other clinical trials H93.1 H93.2, H93.3, H93.8, H93.9 Treatment - Devices Treatment - Devices Other Other Patients group A: in the first and 5th sessions, 5 minutes of Sham Stimulation at a rate of 0.5 Hz, 2 minutes of merely EEG recording ,15 minutes of active TMS with a rate of 0.5 Hz and an intensity of 110% resting motor threshold will be applied respectively. During these two sessions ongoing EEG is being recorded and the coil is placed at Left TemporoParietal (LTP) region. In the second, third and fourth sessions 20 minutes of only active TMS at a rate of 0.5 Hz and an intensity of 110% resting motor threshold will be applied to LTP region. Patients Group B: for this group the treatment-investigative sessions will be the same as patients group A, with the difference that the stimulations are applied at the Left Dorsolateral Prefrontal Cortex (Left DLPFC). Normal group C: During one session, 5 minutes of Sham Stimulation at a rate of 0.5 Hz, 2 minutes of merely EEG recording ,15 minutes of active TMS with a rate of 0.5 Hz and an intensity of 110% resting motor threshold will be applied respectively. During the session ongoing EEG is being recorded and the coil is placed at Left TemporoParietal region. Normal group D: During one session each participant will receive interventions exactly the same as normal Group C with the difference that the stimulations are applied at Left Dorsolateral Prefrontal Cortex (Left DLPFC). Mean energy level difference among EEG frequency bands (delta, theta, alpha, ...) before and after TMS (Transcranial Magnetic Stimulation) in tinnitus participants and normal control group. Timepoint: patients: 26 minutes of simultaneous TMS-EEG in first and last sessions normal subjects: one session of 26 minutes simultaneous TMS-EEG. Method of measurement: recording EEG with active multi electrodes. Comparison of tinnitus severity before and after TMS. Timepoint: At the beginning and end of each session, also before and after active and sham magnetic stimulation. Method of measurement: Visual Analog Scale (VAS) for participants with tinnitus disorder. Comparison of Tinnitus Questionnaire score. Timepoint: At the beginning of the first session and at the end of the last session. Method of measurement: Tinnitus Questionnaire (TQ) for participants with tinnitus disorder. Comparison of Tinnitus Handicap Inventory (THI) score. Timepoint: At the beginning of the first session and at the end of the last session. Method of measurement: Tinnitus Handicap Inventory (THI) for participants with tinnitus disorder. Evaluation of Amplitude, Latency, and Area under the curve of TMS-Evoked Potential Components in tinnitus participants and normal subjects. Timepoint: simultaneous with Transcranial Magnetic Stimulation. Method of measurement: By means of EEG Signal recording. ENT and Head & Neck Research Center Approved 2017-12-10 Ethics committee of Iran university of medical science Iran university of medical science, near to Milad tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)