]>
IRCT20220901055849N1 IRCT 2022-09-06 Tehran University of Medical Sciences Investigating the effect of multi-site transcranial electrical stimulation in the treatment of chronic tinnitus Comparison of the effect of multi-site transcranial electrical stimulation (tES) with different methods on psychophysical, psychological and electroencephalographic (EEG) indicators in people with chronic tinnitus 2023-01-21 anticipated 40 Complete https://irct.ir/trial/65659 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each of the eligible people, randomly and using the minimization method, are allocated in one of the four groups receiving multi-site electrical stimulation. QMinim program (web version of MinimPy software) is used to carry out the process of random allocation using the minimization method. In the minimization method, the first person randomly enters one of the four groups with equal probability. From the second person onwards, participants enter groups with unequal probability (in favor of the group that has the least balance with other groups in terms of the desired variables). This process is done in such a way, that by allocating each participant, the most possible balance is achieved in the distribution of the desired variables among the groups, and at the same time, the number of people in each group is as equal as possible. In this study, the basic probability of each person being in a group with the least balance (compared to other groups) is 85%, Blinding description: The participants have no information about the group to which they have been assigned. But the researcher has all the necessary information to carry out the study. N/A Tinnitus. Intervention 1: First intervention group: In this group, the tDCS-tRNS method is used to provide multi-site electrical stimulation. In each session, first, tDCS stimulation with a current intensity of 2 mA is presented to the DLPFC area, and then, low frequency tRNS stimulation (0.1-100 Hz) with an intensity of 2 mA is presented to the auditory cortex area. Each person receives multi-site electrical stimulation in 8 sessions and in a period of 4 weeks. The total duration of providing multi-site electrical stimulation in each session is 30 minutes, which is divided into two consecutive 15-minute stimulations presented to separate areas in the cortex (multi-site presentation). Intervention 2: Second intervention group: In this group, the tRNS method is used to provide multi-site electrical stimulation. In each session, high-frequency tRNS stimulation (100-640 Hz) was first delivered to the DLPFC region, followed by low-frequency tRNS stimulation to the auditory cortex region. The intensity of the electrical excitation current is equal to 2 mA in both cases. Each person receives multi-site electrical stimulation in 8 sessions and in a period of 4 weeks. The total duration of providing multi-site electrical stimulation in each session is 30 minutes, which is divided into two consecutive 15-minute stimulations presented to separate areas in the cortex (multi-site presentation). Intervention 3: Third intervention group: In this group, the tRNS+DC offset method is used to provide multi-site electrical stimulation. In each session, first, high frequency tRNS stimulation with an intensity of 2 mA plus 1 mA of direct current (DC) is provided to the DLPFC area, and then low frequency tRNS stimulation with an intensity of 2 mA and without DC is presented to the auditory cortex area. Each person receives multi-site electrical stimulation in 8 sessions and in a period of 4 weeks. The total duration of providing multi-site electrical stimulation in each session is 30 minutes, which is divided into two consecutive 15-minute stimulations presented to separate areas in the cortex (multi-site presentation). Intervention 4: Control group: In this group, the electrical stimulation protocol is similar to the tDCS-tRNS group, with the difference that the electrical stimulation in each of the tDCS and tRNS modes is provided only for 30 seconds and then the electrical current is stopped. The purpose of providing sham stimulation is that the participant feels the passage of electrical current through his skin and cannot distinguish between receiving real and sham stimulation, so as to prevent bias in the research results. Yes - There is a plan to make this available What will be shared: All the data related to the investigated indicators can be shared. When: One year after the publication of study results in scientific journals To whom: Researchers working in academic centers or prestigious research institutes Conditions: Further publication and analysis of the data must be done with the permission of the researcher. Where to obtain: Sahand Nazeri S_nazeri@razi.tums.ac.ir How to obtain: Providing the purpose of the data request along with the scientific resume via email Comments:
public Sahand Nazeri
No. 336, َAt the corner of Safialishah St., Enghelab Ave.
Tehran Iran (Islamic Republic of) 1436913545 +98 21 7768 4889 S_nazeri@razi.tums.ac.ir Tehran University of Medical Sciences scientific Farzaneh Fatahi
No 336, At the corner of Safialishah St., Enghelab Ave.
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7768 4889 Jfatahi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age range from 18 to 60 years At least six months of persistent non-pulsatile tinnitus perception Normal hearing thresholds (below 25 dB HL) at frequencies from 250 to 2000 Hz and hearing thresholds below 40 dB HL at frequencies above 2000 Hz The normal state of the outer and middle ear (normal otoscopy and obtaining a type A tympanogram with a static compliance between 0.3 and 1.6) Passing at least six months since receiving transcranial electrical or magnetic stimulation (regardless of the purpose of stimulation and the stimulation protocol used) Having the necessary abilities to perform the tests 18 years 60 years Both Perceiving polyphonic tinnitus Observing a conductive component (Air-Bone Gap ≥ 15 dB HL) in the audiogram Formal music training Having diseases of the ear, nose and throat The existence of obvious cognitive disorders and mental disability Suffering from chronic neurological diseases Suffering from chronic psychiatric disorders A history of alcohol and drug abuse or addiction Taking drugs that affect the function of the central nervous system A history of severe head trauma or surgery related to the central nervous system in the head and neck area Receiving other conventional treatment methods for tinnitus in at least the last six months Using a heart pacemaker or implantable electrodes in the head and neck area Pregnancy H93.1 Tinnitus Treatment - Devices Treatment - Devices Treatment - Devices Placebo First intervention group: In this group, the tDCS-tRNS method is used to provide multi-site electrical stimulation. In each session, first, tDCS stimulation with a current intensity of 2 mA is presented to the DLPFC area, and then, low frequency tRNS stimulation (0.1-100 Hz) with an intensity of 2 mA is presented to the auditory cortex area. Each person receives multi-site electrical stimulation in 8 sessions and in a period of 4 weeks. The total duration of providing multi-site electrical stimulation in each session is 30 minutes, which is divided into two consecutive 15-minute stimulations presented to separate areas in the cortex (multi-site presentation). Second intervention group: In this group, the tRNS method is used to provide multi-site electrical stimulation. In each session, high-frequency tRNS stimulation (100-640 Hz) was first delivered to the DLPFC region, followed by low-frequency tRNS stimulation to the auditory cortex region. The intensity of the electrical excitation current is equal to 2 mA in both cases. Each person receives multi-site electrical stimulation in 8 sessions and in a period of 4 weeks. The total duration of providing multi-site electrical stimulation in each session is 30 minutes, which is divided into two consecutive 15-minute stimulations presented to separate areas in the cortex (multi-site presentation). Third intervention group: In this group, the tRNS+DC offset method is used to provide multi-site electrical stimulation. In each session, first, high frequency tRNS stimulation with an intensity of 2 mA plus 1 mA of direct current (DC) is provided to the DLPFC area, and then low frequency tRNS stimulation with an intensity of 2 mA and without DC is presented to the auditory cortex area. Each person receives multi-site electrical stimulation in 8 sessions and in a period of 4 weeks. The total duration of providing multi-site electrical stimulation in each session is 30 minutes, which is divided into two consecutive 15-minute stimulations presented to separate areas in the cortex (multi-site presentation). Control group: In this group, the electrical stimulation protocol is similar to the tDCS-tRNS group, with the difference that the electrical stimulation in each of the tDCS and tRNS modes is provided only for 30 seconds and then the electrical current is stopped. The purpose of providing sham stimulation is that the participant feels the passage of electrical current through his skin and cannot distinguish between receiving real and sham stimulation, so as to prevent bias in the research results. Tinnitus psychophysical loudness. Timepoint: Before, after and three months after the electrical stimulation sessions. Method of measurement: Loudness matching. Tinnitus loudness. Timepoint: Before, after and three months after the electrical stimulation sessions. Method of measurement: Visual Analogue Scale (VAS). Tinnitus annoyance. Timepoint: Before, after and three months after the electrical stimulation sessions. Method of measurement: Visual Analogue Scale (VAS). The degree of tinnitus handicap. Timepoint: Before, after and three months after the electrical stimulation sessions. Method of measurement: Tinnitus Handicap Inventory (THI). The degree of negative effects of tinnitus. Timepoint: Before, after and three months after the electrical stimulation sessions. Method of measurement: Tinnitus Functional Index (TFI). Satisfaction with quality of life. Timepoint: Before, after and three months after the electrical stimulation sessions. Method of measurement: SF-36 Questionnaire. Severity of depression. Timepoint: Before, after and three months after the electrical stimulation sessions. Method of measurement: Beck Depression Inventory-Second Edition (BDI-II). Severity of anxiety. Timepoint: Before, after and three months after the electrical stimulation sessions. Method of measurement: Beck Anxiety Inventory (BAI). Absolute power of EEG frequency bands. Timepoint: Before, after and three months after the electrical stimulation sessions. Method of measurement: EEGLAB software. Relative power of EEG frequency bands. Timepoint: Before, after and three months after the electrical stimulation sessions. Method of measurement: EEGLAB software. Current source density. Timepoint: Before, after and three months after the electrical stimulation sessions. Method of measurement: sLORETA software. Tinnitus pitch. Timepoint: Before, after and three months after the electrical stimulation sessions. Method of measurement: Pitch matching. Tehran University of Medical Sciences Approved 2022-08-31 Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o Central Organization of Tehran University of Medical Sciences, At the corner of Qods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)