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

Investigating and comparing the effect of different multi-site transcranial electrical stimulation methods on psychophysical, psychological and electroencephalographic indicators of tinnitus in people with chronic tinnitus.

The present study is an intervention in the form of a randomized clinical trial with a parallel and single blind design. 40 people participated in the study in the form of four separate groups receiving multi-site electrical stimulation including: tDCS-tRNS group, tRNS group, tRNS+DC offset group and sham group.

After completing the informed consent form and performing basic assessments (before stimulation), people in each group will receive the desired electrical stimulation in 8 sessions. After the end of the sessions and three months after that, all people will be evaluated again. This study is conducted in Tehran University of Medical Sciences.

Conditions of entry: age range from 18 to 60 years, at least six months of non-pulsatile tinnitus perception, Normal or almost normal hearing status and having of the necessary ability to perform the tests Conditions of non-entry: not understanding polyphonic tinnitus, and not suffering from ear, nose and throat diseases, chronic neurological diseases and psychiatric disorders

The intervention groups include three experimental groups and one control group. People in the experimental groups received three different types of multi-site electrical stimulation, and in the control group, participants received sham stimulation.

Tinnitus psychophysical loudness; Tinnitus loudness and annoyance; The degree of tinnitus handicap; The degree of negative effects of tinnitus; Satisfaction with quality of life; Severity of depression and anxiety; Absolute and relative power of EEG frequency bands; Current source density

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%.

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.

All the data related to the investigated indicators can be shared.

One year after the publication of study results in scientific journals

Researchers working in academic centers or prestigious research institutes

Further publication and analysis of the data must be done with the permission of the researcher.

Sahand Nazeri S_nazeri@razi.tums.ac.ir

Providing the purpose of the data request along with the scientific resume via email